Identity
- Trade Name
- COVID-19 Coronavirus Real Time PCR Kit FDA UDI
- Generic Name
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 50 Tests FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973342000158 FDA UDI
- FDA Product Code
- QQX FDA UDI
- GMDN Term
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3981 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
COVID-19 Coronavirus Real Time PCR Kit by Jiangsu Bioperfectus Technologies Co., Ltd. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT).
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- Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay Kit — LIFE TECHNOLOGIES LIMITED · Class II
- Simplexa COVID-19 Positive Control GEN II Pack — DiaSorin Molecular LLC · Class II
- Accula SARS-CoV-2 Test — MESA BIOTECH, INC. · N
- Lyra — DIAGNOSTIC HYBRIDS, INC. · N
- EURORealTime SARS-CoV-2 — EUROIMMUN Medizinische Labordiagnostika AG · N
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
Sources (2)
- FDA UDI 5cb70f8e-018f-482b-a79a-9400279bdbf1 32 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026