Identity
- Trade Name
- ID NOW™ COVID-19 FDA UDI
- Generic Name
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in respiratory specimens. FDA UDI
- Model / Reference
- 190-000 FDA UDI
- Description
- A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in respiratory specimens. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877011269 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
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Id Now™ Covid-19 by Alere Scarborough, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI 84d30b14-4efd-4a2e-bc18-9390d79ffa1e 34 fields · synced Jun 8, 2026