Covid-19 test kit

1. COVID-19 RT-PCR Kit
(Ultra Sensitivity)
Merlin Biomedical (Xiamen) Co., Ltd.
4th Floor, Building B3, No. 2054 West Wengjiao Rd.,
Haicang, Xiamen 361028, China
Tel/Fax: +86 592 5210 772
Email: minfenglin@merlinbio.com.cn
www.merlinbio.com.cn
Lotus NL B.V.
Contact person: Peter
Address: Koningin Julianaplein 10,1e Verd,2595AA, The
Hague, Netherlands.
Telephone: +31644168999
E-mail: peter@lotusnl.com

5. Farmatec
Bezoekadres:
Hoftoren
Rijnstraat 50
2515 XP Den Haag
T 070 340 6161
http://hulpmiddelen.farmatec.nl
Inlichtingen bij:
T.I. van Langeveld - Baas
medische_hulpmiddelen@
minvws.nl
Ons kenmerk:
CIBG-20202030
Bijlagen
-
Uw aanvraag
10 mei 2020
Correspondentie uitsluitend
richten aan het retouradres met
vermelding van de datum en
het kenmerk van deze brief.
Pagina 1 van 2
> Retouradres Postbus 16114 2500 BC Den Haag
Lotus NL B.V.
T.a.v. de heer X. Wei
Koningin Julianaplein 10
2595 AA 's-Gravenhage
Datum: 2 juni 2020
Betreft: aanmelding In-vitro diagnostica
Geachte heer Wei,
Op 10 mei 2020 ontving ik uw notificatie krachtens artikel 4, eerste lid van het
Nederlandse Besluit in-vitro diagnostica (BIVD) om onder de bedrijfsnaam Merlin
Biomedical (Xiamen) Co., Ltd met Europees gemachtigde Lotus NL B.V.
onderstaand product als in-vitro diagnosticum op de Europese markt te brengen.
Het product staat geregistreerd als in-vitro diagnosticum onder nummer:
Novel Coronavirus (COVID­19) RT­PCR Kit,2019­nCoV IgG/IgM Rapid
Test Cassette,Single Use Specimen Container
(geen merknaam) (NL­CA002­2020­51178)
Hiermee heeft u voldaan aan uw verplichting op grond van artikel 4, BIVD.
In alle verdere correspondentie betreffende bovenvermeld product verzoek ik u dit
nummer te vermelden. Aan dit nummer kunnen geen verdere rechten ontleend
worden, het dient alleen om de notificatie administratief te vergemakkelijken.
De registratie van in-vitro diagnostica als medisch hulpmiddel op grond van de
Classificatiecriteria (Bijlage II) bij Richtlijn 98/79/EG betreffende medische
hulpmiddelen voor in-vitro diagnostiek is onderhevig aan mogelijke revisies van
Europese regelgeving inzake de classificatie van medische hulpmiddelen en aan
voortschrijdend wetenschappelijk inzicht (zie artikel artikel 10, eerste lid van
Richtlijn 98/79/EG).

6. Pagina 2 van 2
Notificatie van in-vitro diagnostische medische hulpmiddelen impliceert dat de
fabrikant, Merlin Biomedical (Xiamen) Co., Ltd de CE-conformiteitsmarkering heeft
aangebracht op het desbetreffende product alvorens het in een EU-lidstaat in de
handel te brengen. Zodoende garandeert Lotus NL B.V. dat het in-vitro
diagnosticum voldoet aan de essentiële eisen zoals opgenomen in bijlage I bij
Richtlijn 98/79/EG (en in het daarmee corresponderende onderdeel 1 bij het
besluit)
Volledigheidshalve wijzen wij u erop dat een in-vitro diagnosticum moet voldoen
aan de eisen uit het BIVD. Het BIVD is gebaseerd op Richtlijn voor in-vitro
diagnostiek, 98/79/EG. Met name wijzen wij u op de Nederlandse-taaleis zoals
deze in Nederland geldt, de eisen voor het ter beschikking houden van de
technische documentatie en de plicht tot het hebben van een Post Marketing
Surveillance- en vigilantiesysteem.
Tot slot merk ik op dat met uw notificatie - de administratieve notificatie als
fabrikant - en deze brief geen sprake is van een oordeel over de status of
kwalificatie van uw product: notificering betekent niet dat daadwerkelijk sprake is
van een in-vitro diagnosticum in de zin van de onderhavige wet- en regelgeving.
In voorkomende gevallen kan de Inspectie Gezondheidszorg en Jeugd (IGJ),
belast met het toezicht op de naleving van het bij of krachtens de wet bepaalde,
een standpunt innemen over de status van een product, waarbij het volgens vaste
jurisprudentie uiteindelijk aan de nationale rechter is om te bepalen of een
product onder de definitie van in-vitro diagnosticum valt.
De Minister voor Medische Zorg en Sport,
namens deze,
Afdelingshoofd
Farmatec
Dr. M.J. van de Velde

7. Acknowledgment Letter
10/20/2020
Pearl Chen
Merlin Biomedical (Xiamen) Co., Ltd.
4th Floor, Building B3, 2054 West Wengjiao Rd., Haicang
Xiamen 361028
CHINA
Dear Pearl Chen:
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration
(FDA) has received your submission. This submission has been assigned the unique document
control number below. All future correspondence regarding this submission should be identified
prominently with the number assigned and should be submitted to the Document Control
Center at the above letterhead address. Failure to do so may result in processing delays. If you
believe the information identified below is incorrect, please contact the Office of Product
Evaluation and Quality (OPEQ) submission support at (301) 796-5640 or
OPEQSubmissionSupport@fda.hhs.gov.
Submission Number: EUA202911
Received: 10/20/2020
Applicant: Merlin Biomedical (Xiamen) Co., Ltd.
Device: Novel Coronavirus (COVID-19) RT-PCR Kit
We will notify you when the review of this document has been completed or if any additional
information is required. For information about CDRH review regulations and policies, please
refer to http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm.
Sincerely yours,
Center for Devices and Radiological Health
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

9. Rx Only Merlin Biomedical (Xiamen) Co., Ltd.
1 / 3
Novel Coronavirus (COVID-19)
RT-PCR Kit
Instruction for Use
Product:
Novel Coronavirus (COVID-19) RT-PCR Kit
Specification:
Cat No Target Gene Size
CP01020011 ORF1ab/N 50T
CP01980011 ORF1ab/N/E 50T
CP02400011 ORF1ab/N 96T
CP02410011 ORF1ab/N/E 96T
Intended Use:
The kit is a qualitative in vitro diagnostic test for nucleic acid detection of
SARS-CoV-2 ORF1ab, E and N gene from human respiratory tract
secretion samples of suspected SARS-CoV-2-infected pneumonia cases,
suspected clustered infection cases, and others who need SARS-CoV-2
infection diagnosis or differential diagnosis. The test results are only used
for auxiliary diagnosis.
Summary：
Coronaviruses are a large family of viruses that are enveloped single
stranded positive sense RNA viruses which cause illnesses in both
human and animals. The illness has ranged from common cold (e.g.
respiratory syndrome, fever, cough, etc.) to more severe diseases such
as pneumonia and severe acute respiratory syndrome.
Test Principle:
The kit is based on real-time PCR method and technology of fluorescent
probes to detect specific nucleic acid sequences of SARS-CoV-2
ORF1ab, E and N gene from human respiratory tract secretion samples
which indicates the infection of the above pathogens.
The PCR reagent of the kit contains UDG enzyme to selectively cleave
the uracil glycosidic bond of uracil-containing PCR fragment for effectively
reducing false positives caused by PCR product contamination.
Kit Contents:
The kit contains the following materials.
For CP01020011, CP01980011：
Tube
No.
Contents Volume (μL/tube) Quantity
① Freeze-dried Buffer Mix
780μL after
reconstituted
1 vial
② Diluent 1000μL 1 vial
③ Buffer PC
50μL after
reconstituted
1 vial
④ Buffer NC 100μL 1 vial
For CP02400011, CP02410011：
Tube
No.
Contents Volume (μL/tube) Quantity
① Freeze-dried Buffer Mix
PCR 8-tube，
50μL/Well after
reconstituted
96 vials
② Diluent 1000μL 1 vial
③ Buffer PC
200μL/vial after
reconstituted
5 vials
④ Buffer NC 1000μL 1 vial
Storage and Stability:
Store at 2~8℃ in dark.
Transport at 2 ~28℃ within 15 days.
Shelf life: 12 months.
Note: Freeze-dried Buffer Mix should be stored at -20 ± 5℃ after reconstituted, valid for 48 hours.
Buffer PC should be stored at -20 ± 5 ℃ after reconstituted, valid for 6 months. Repeated thawing and
freezing reagents more than 3 times should be avoided as this may affect performance.
Materials Required (but not provided):
1) Compatible PCR instruments:
Agilent Mx-3000p, Agilent Mx-3005p, ABI QuantStudio 3, ABI7500,
Molarray MA-6000, Hongshi SLAN-96, Tianlong Gentier 96E, Gentier 48S,
Gentier 48E, LightCycler480II.
2) Viral RNA extraction kit.
3) Biosafety cabinet.
4) Vortex.
5) Mini centrifuge with rotor for centrifuge tubes.
6) Personal Protective Equipment (PPE): Disposable powder-free gloves,
goggles/face shield, respirators (NIOSH-certified N95 is recommended.)
7) Nuclease-free centrifuge tubes.
8) Nuclease-free PCR tubes and caps.
9) Adjustable pipettors and sterile, nuclease-free pipet tips.
10) Biohazard waste container.
11) Tube racks.
12) RNase-Free ddH2O.
Precautions and Warnings:
General Precautions
• For in vitro test only. Please read the instruction carefully and become
familiar with all components of the kit prior to use, and strictly follow the
instruction during operation.
• Please check the compatible real-time PCR instruments prior to use.
• DO NOT use the kit or any kit component after expiry date.
• DO NOT use any other reagents from different lots in the tests.
• DO NOT use any other reagent in this kit.
• Thaw reagents shall be stored at -20℃ for use within 2 days avoiding
repeated freezing and thawing.
Handling Precautions
• Handle all specimens and components of the kit as potentially infectious
material according to safe laboratory procedures.
• Only trained professionals can use this kit. Wear appropriate personal
protective equipment (PPE) when working with clinical specimens.
• Specimen processing should be performed in a certified Class II
biosafety cabinet following biosafety level 2 or higher guidelines.
• Avoid skin, eyes and mucous membranes contact with the chemicals. In
case of contact, flush with water immediately.
• DO NOT pipet by mouth.
• Avoid aerosols.
Safety Precautions
• The kit contains positive control; strictly distinguish the positive control
from other reagents to avoid contamination which may cause false
positive.
• PCR amplification is extremely sensitive to cross-contamination. The
flow of tubes, racks, pipets and other materials used should be from pre-
amplification to post-amplification, and never backwards.
• Gloves should be worn and changed frequently when handling samples
and reagents to prevent contamination.
• Using separate, dedicated pipettes and nuclease-free filtered pipette tips
when handling samples and reagents to prevent exogenous RNA
contamination to the reagents.
• Please pack the post-amplification tubes with two disposable gloves and
discard properly. DO NOT open the post- amplification PCR tubes.
• All disposable materials are for one time using. DO NOT reuse.
• The unused reagents, used kit, and waste must be disposed of properly.
• After the experiment, wipe down the work area, spray down the pipettes
and equipment with 75% ethanol or 10% hypochlorous acid solution.
Specimen Collection and Preparation:

10. Rx Only Merlin Biomedical (Xiamen) Co., Ltd.
2 / 3
• Viral RNA extracted from human respiratory specimens should be
collected, including upper respiratory specimen (nasopharyngeal or
pharyngeal extracts, washes or swabs) and lower respiratory
specimens (bronchoalveolar lavage samples, tracheal extracts or deep
cough sputum).
• Swab specimens should be collected only on swabs with a synthetic tip
with aluminum or plastic shafts. Swabs with calcium alginate or cotton
tips with wooden shafts are not acceptable.
• The samples should be extracted RNA immediately. For short-term
storage of up to 24 hours, the sample should be stored at 2~8℃. For
long-term storage of over 24 hours, the sample should be stored at -
70℃ and avoid repeated freezing-thawing.
Assay Procedure:
For CP01020011, CP01980011
RNA Extraction
1）Add 50μLRNase-Free ddH2O to dissolve Buffer PC(Positive
Control), vortex and centrifuge briefly. Add 5μL of Buffer PC for RNA
extraction.Please refer to operation manual of RNA extraction or
purification reagents for detailed procedure.
2）Viral RNA extraction or purification reagents are not included in this
kit.
Viral RNA Detection
1) Take the Freeze-dried Buffer Mix and Diluent out of the kit from the
freezer.
2) Add 780μL Diluent to dissolve Freeze-dried Buffer Mix and ensure it is
evenly blended.
3) Prepare enough Master Mix in separate sterile centrifuge tube
according to the ratio in below Table. The volume of Master Mix should
be sufficient for tests of <n> samples, positive control and negative
control.
Content Volume per test
Buffer Mix 15μL
Note: Every PCR run must contain one Positive Control and one Negative
Control (Buffer NC).
4) Prepare PCR tubes for Sample/PC/NC, dispense 15μL Master Mix into
each PCR tube respectively.
5) Add 15μL Buffer NC (vortex and centrifuge before use) to the reaction
tube, cap the tube.
6) Add 15μL sample RNA to the reaction tube, cap the tube.
7) Add 15μL Positive Control to the reaction tubes, cap the tube.
Note: Suggest following below adding order: NC → samples → PC,
and use filtered tips for all pipetting steps to avoid cross-contamination.
8) Briefly centrifuge the PCR strips to collect all liquid at the bottom of
each PCR tube.
9) Place the PCR strips into the real-time PCR instrument.
10) Setup the PCR Protocol using the cycling parameters in below
Table.
Stage Cycles Temp. Time Data
Reverse
Transcription
1 48℃ 15min /
Initial
denaturation
1 93℃ 2 min /
Cycle Reaction 45
93℃ 15s /
58℃ 40s
Fluorescence
Collection
Device Cooling 1 30℃ 30s /
For CP01020011:
Target Channel Quencher
ORF1ab FAM None
N HEX/VIC/JOE None
Internal
Control
Cal Red 610/ROX/TEXAS RED None
For CP01980011:
Target Channel Quencher
ORF1ab FAM None
N HEX/VIC/JOE None
E Cy5 None
Internal
Control
Cal Red 610/ROX/TEXAS RED None
11) Start the PCR run immediately.
12) When the PCR run is finished, analyze the data according to the
“Results Interpretation” procedures.
For CP02400011, CP02410011
RNA Extraction
1) Add 200μLDiluent to dissolve Buffer PC(Positive Control), vortex and
centrifuge briefly. Add 200μL of Buffer PC for RNA extraction.Please refer
to operation manual of RNA extraction or purification reagents for detailed
procedure to samples and Positive Control /Negative Control RNA
extraction.
2) Viral RNA extraction or purification reagents are not included in this kit.
Viral RNA Detection
1) Take the Freeze-dried Buffer Mix out of the kit from the freezer.
2) Prepare enough Freeze-dried Buffer Mix for tests of <n> samples,
positive control and negative control.
Note: Every PCR run must contain one Positive Control and one Negative
Control (Buffer NC).
3) Add 50μL Buffer NC (vortex and centrifuge before use) to the reaction
tube, cap the tube.
4) Add 50μL sample RNA to the reaction tube, cap the tube.
5) Add 50μL Positive Control to the reaction tubes. Cap the tube.
Note: Suggest following below adding order: NC → samples → PC, and
use filtered tips for all pipetting steps to avoid cross-contamination.
6) Briefly centrifuge the PCR strips to collect all liquid at the bottom of each
PCR tube.
7) Place the PCR strips into the real-time PCR instrument.
8) Setup the PCR Protocol using the cycling parameters in below Table.
Stage Cycles Temp. Time Data
Reverse
Transcription
1 48℃ 15min /
Initial
denaturation
1 93℃ 2 min /
Cycle Reaction 45
93℃ 15s /
58℃ 40s
Fluorescence
Collection
Device Cooling 1 30℃ 30s /
For CP02400011:
Target Channel Quencher
ORF1ab FAM None
N HEX/VIC/JOE None
Internal
Control
Cal Red 610/ROX/TEXAS RED None
For CP02410011:
Target Channel Quencher
ORF1ab FAM None
N HEX/VIC/JOE None
E Cy5 None
Internal
Control
Cal Red 610/ROX/TEXAS RED None
9) Start the PCR run immediately.
10) When the PCR run is finished, analyze the data according to the
“Results Interpretation” procedures.
Calculation:
Baseline setting: Adaptive baseline.
Threshold setting: Threshold line should be set just above the peak of the
normal negative control amplification curve (irregular noise line).
Quality Control:
Before data analysis, the result of control items should be checked in
following Table:
For CP01020011/CP02400011:
Result of Control
Negative
Control
Positive
Control
Cal Red 610/ROX/TEXAS RED
(Inner Control, β-actin) Ct≥42
or No Ct
Ct＜42
FAM (ORF1abGene)
HEX/VIC/JOE (N Gene)
For CP01980011/CP02410011:
Result of Control
Negative
Control
Positive
Control
FAM (ORF1ab gene) Ct≥42 or No Ct Ct＜42

11. Rx Only Merlin Biomedical (Xiamen) Co., Ltd.
3 / 3
HEX/VIC/JOE (N gene)
Cy5 (E gene)
Cal Red 610/ROX/TEXAS RED
(Inner Control, β-actin)
Results Interpretation：
If the negative/positive control results meet the above "Quality Control ",
Interpretation of Ct value of the target gene detection according to below
Table:
For CP01020011/CP02400011:
Result of
Sample
ROX (Inner
Control, β-actin)
FAM (ORF1ab
Gene)
HEX
(N Gene)
Negative Ct＜40, with good
amplification curve
Ct≥42 or No Ct
Ct≥42 or No
Ct
Positive Ct＜42 Ct＜42
Suspicious results: for FAM or HEX, 42≤Ct<45, repeat experiment. If Ct
<42 with good amplification curve, the sample is judged to be positive;
otherwise, it is negative.
For CP01980011/CP02410011:
Test result Negative (-) Positive (+)
FAM (ORF1ab gene)
Ct≥42 or No Ct Ct＜42
HEX/VIC/JOE (N gene)
Cy5 (E gene)
Cal Red 610/ROX/TEXAS RED
(Inner Control, β-actin)
Based on the above test results, the sample result interpretation is as
follows:
Result of Sample Result interpretation
ORF1ab, N gene and E gene
are all (+)
SARS-CoV-2 positive
ORF1ab (+) and N gene (+)
ORF1ab (+) and E gene (+)
Only ORF1ab gene (+) Repeat the test. If it is still (+), it will be
interpreted as SARS-CoV-2 positive.
Only ORF1ab gene (-) Repeat the test. If ORF1ab, and N
gene and/or E gene are (+), interpret
the result as SARS-CoV-2 positive;
Otherwise interpret the result as
suspect who need to be retested the
other time.
ORF1ab (-) and N gene (+)
ORF1ab (-) and E gene (+)
ORF1ab, N gene and E gene
are all (-)
SARS-CoV-2 negative
Limitation:
• The test result of this product is positive, which can indicate the
presence of SARS-CoV-2 in the tested samples. The clinical diagnosis
and treatment of patients should be considered in combination with
other symptoms/signs, medical history, other laboratory tests and
treatment responses.
• The test results are related to the process of sample collection, transfer,
storage and processing, and any mistakes may lead to inaccurate
results. If cross-contamination is not properly controlled during sample
processing, false positive results may occur.
• The test is limited to the specified extraction reagents, specimen types,
and applicable instruments. Other unverified situations require
laboratory verification before use.
• During the design of this product, relatively conservative fragments of
viral nucleic acids were selected for amplification and detection, but the
virus gene is possible to mutate. Although the mutation rate in the
conservative region which selected for amplification detection is very
small, but the possibility cannot be completely avoided theoretically.
• This product cannot be used for the differential diagnosis of SARS.
• Test results shall be determined according to the “result interpretation”.
Performance Characteristics:
Appearance: Clean, clearly marked, no leakage.
Sensitivity:
For CP01020011/CP01980011: 200 copies/mL.
For CP02400011/CP02410011: 100 copies/mL.
Coincidence rate of positive reference: 100%.
Coincidence rate of negative reference: 100%.
Precision: CV≤5%.
Reference:
1. Heid, C. A., Stevens, J., Livak, K. J., et al. Real time quantitative
PCR[J]. Genome Research,1996,6(10), 986–994.
Merlin Biomedical (Xiamen) Co., Ltd.
Add: 4th Floor, Building B3,
2054 West Wengjiao Rd.,
Haicang, Xiamen, 361028, China
Tel: 86-592-5210772; 86-592-5210773
Fax: 86-592-5210772
Email: info@merlinbio.com.cn
Website: http://www.merlinbio.com.cn
Lotus NL B.V.
Contact person: Peter
Address: Koningin Julianaplein 10,1e Verd,2595AA,
The Hague,Netherlands.
Telephone: +31644168999
E-mail:peter@lotusnl.com
Instruction Approval and Revision Date:
Approval Date: 05 Jun 2020
Revision Date: 03 Nov 2021
Date of Issue: 03 Nov 2021
Catalogue number Temperature limit
Consult instructions for use Batch code
In vitro diagnostic medical
device
Use-by date
Manufacturer Biological risks
This way up Keep dry
Warning
Avoid overexposure to the
sun
Don't use the product when the
package is damaged
Authorized representative
in the European
Community
Date of manufacture
Contains sufficient for <n>
tests
Do not re-use Rx Only
CAUTION!
US Federal Law restricts
this device to sale by or on
the order of a physician.

12. Certificate
No. Q5 106286 0001 Rev. 01
Page 1 of 2
TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany
Holder of Certificate: Merlin Biomedical (Xiamen) Co., Ltd.
Unit 01, 4th Floor, Building B3
Xiamen Biological Medicine Industrial Park
2054 West Wengjiao Road, Haicang
361028 Xiamen
PEOPLE'S REPUBLIC OF CHINA
Certification Mark:
Scope of Certificate: Design and Development, Production and
Distribution of In Vitro Diagnostic Medical
Devices for Detection Kit of 5 Urogenital
Tract Pathogens Nucleic Acid
(Fluorescence PCR method), Single Use
Specimen Container, DNA/RNA Extraction
Kit, IVD Equipment for Nucleic Acid
Purification integrated with Amplification
based on Fluorescence PCR Method
The Certification Body of TÜV SÜD Product Service GmbH certifies that the company mentioned
above has established and is maintaining a quality management system, which meets the
requirements of the listed standard(s). All applicable requirements of the testing and certification
regulation of TÜV SÜD Group have to be complied with. For details and certificate validity see:
www.tuvsud.com/ps-cert?q=cert:Q5 106286 0001 Rev. 01
Report No.: GZ2135501
Valid from: 2021-08-02
Valid until: 2023-06-08
Date, 2021-08-02 Christoph Dicks
Head of Certification/Notified Body

13. Certificate
No. Q5 106286 0001 Rev. 01
Page 2 of 2
TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany
Applied Standard(s): EN ISO 13485:2016
Medical devices - Quality management systems -
Requirements for regulatory purposes
(ISO 13485:2016)
DIN EN ISO 13485:2016
Facility(ies): Merlin Biomedical (Xiamen) Co., Ltd.
Unit 01, 4th Floor, Building B3, Xiamen Biological Medicine
Industrial Park, 2054 West Wengjiao Road, Haicang, 361028
Xiamen, PEOPLE'S REPUBLIC OF CHINA
Design and Development, Production of IVD Equipment for
Nucleic Acid Purification integrated with Amplification based on
Fluorescence PCR Method.
Production of In Vitro Diagnostic Medical Devices for Detection Kit
of 5 Urogenital Tract Pathogens Nucleic Acid (Fluorescence PCR
method), Single Use Specimen Container, DNA/RNA Extraction Kit
Merlin Biomedical (Xiamen) Co., Ltd.
4th Floor, Building B11, Xiamen Biological Medicine Industrial
Park, 2070 West Wengjiao Road, Haicang, 361028 Xiamen,
PEOPLE'S REPUBLIC OF CHINA
Design and Development, Production and Distribution of Detection
Kit of 5 Urogenital Tract Pathogens Nucleic Acid (Fluorescence
PCR method), Single Use Specimen Container, DNA/RNA
Extraction Kit.
Production and Distribution of IVD Equipment for Nucleic Acid
Purification integrated with Amplification based on Fluorescence
PCR Method.
.