Identity
- Trade Name
- Smart DetectTM SARS-CoV-2 rRT-PCR Kit FDA UDI
- Generic Name
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- EUA FDA UDI
- Model / Reference
- COV2-E FDA UDI
- Description
- EUA FDA UDI
Identifiers
- Primary DI / UDI-DI
- B379COV2E0 FDA UDI
- FDA Product Code
- QJR FDA UDI
- GMDN Term
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Smart DetectTM SARS-CoV-2 rRT-PCR Kit by InBios International, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- InBios International, Inc.
Sources (1)
- FDA UDI 03a9877d-4b9b-486b-b4ba-74490a3919c7 33 fields · synced Jun 9, 2026