2019 Novel Coronavirus
(2019-nCoV) RNA Detection kit
( Fluorescent PCR)
Pack with 24/48/96 tests
Time for a result: several hours for whole process
Necessary Equipment to use: Throat Swap, RNA extraction kit, Polymerase chain reaction machine, ABI Prism 7500 Sequence Detection System, Roche LightCycler 480 Instrument Operator
Accuracy of the the test: 99.9%
Coronavirus RNA Detection kit (Fluorescent PCR)
This product is a qualitative in vitro nucleic acid amplification assay used to detect SARS-CoV-2. The Coronavirus test kit is widely used for rapid detection and outbreak control of COVID-19 in China. It’s also a WHO Emergency Use Listing of IVD products.
With its high specificity, sensitivity and rapid response, it can effectively assist the diagnosis of disease and improve the diagnosis efficiency.
Description
Description
Technical Specifications
- CE EC-REP
- It has a high specificity, sensitivity and rapid response
- It can effectively assist the diagnosis of disease and improve the diagnosis efficiency.
- This test needs to be carried out by medical staff only in the hospital PCR laboratory.
- Applicable instruments: Throat Swap, RNA extraction kit, Polymerase chain reaction machine, ABI Prism 7500 Sequence Detection System, Roche LightCycler 480 Instrument Operator
- Accuracy of testing: 99.9%
- Valid Period: -20±5℃，6 months
- Packing unit: box with 96 tests, 70 boxes in one carton
Additional information
| Item | Details | Remark |
| China Ministry of Commerce White List Producer | Yes | CE/WHO Emergency use listing of IVDs |
| CE Certificatte | Medical Device Safety Service | EC-REP |
| Test Reports by | National Institution of Food and Drug Control, China | CNAS approved Testing lab |
| Applied Standard | Directive 98/79/EC on Vitro Diagnostic Medical device | |
| Factory ISO certificates | ISO 13485 | |
| Product classification | Medical use | |
| Packaging | 96 pcs / box 70 boxes / ctn 30 kg / ctn |
Additional information
Additional information
| Manufacturer license type | medical |
|---|---|
| ISO Certificate | ISO 13485 |
| ISO Certification Issuer | BSI |
| White list manufacturer | yes |
| Certification standard | CE, GB, WHO Emergency Use listing of IVDs |
| General EN standard | Directive 98/79/EC on Vitro Diagnostic Medical device |
| CE certification issuer | Medical Device Safety Service as EU representative |
| Number of CE Certification | N.A |
| Manufacturer standards | Directive 98/79/EC on Vitro Diagnostic Medical device |
| Test report authorized nr | L 0001 |
| Manufacturer test report | CNAS approved test lab, National Institution of Food and Drug Control, China |
| China declaration | No |
| Valid CE | Yes |
| Packaging specs | 96 persons/box, 70 boxes/ Ctn |
| GW carton (kg) | 30 |
| CTN size (cm) | 68*58*42 |
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