Identity
- Trade Name
- ID NOW COVID-19 2.0 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 anterior nasal swab and nasopharyngeal swab specimens. FDA UDI
- Model / Reference
- 192-000 FDA UDI
- Description
- A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in anterior nasal swab and nasopharyngeal swab specimens. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811877011354 FDA UDI
- 510(k) Number
- K221925 FDA UDI
- FDA Product Code
- QWR 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
- 866.3982 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
No
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)
Id Now Covid-19 2.0 by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT).
- RealTime — Abbott Molecular · N
- ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (8x48) — VELA OPERATIONS SINGAPORE PTE. LTD.
- cobas liat SARS-CoV-2 v2 nucleic acid test — Roche Molecular Systems, Inc. · Class II
- 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
Cleared under the same submission
K221925 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI 70425b44-61e2-4caa-aaf4-40f79127423a 34 fields · synced May 30, 2026