Identity
- Trade Name
- ID NOW COVID-19 2.0 Control Swab Kit FDA UDI
- Generic Name
- SARS-CoV-2 nucleic acid IVD, control FDA UDI
- Device Name
- Control Swabs intended for use only with the ID NOW™ COVID-19 2.0 product. Refer to the ID NOW COVID-19 2.0 Product Insert for instructions for use. FDA UDI
- Model / Reference
- 192-080 FDA UDI
- Description
- Control Swabs intended for use only with the ID NOW™ COVID-19 2.0 product. Refer to the ID NOW COVID-19 2.0 Product Insert for instructions for use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811877011361 FDA UDI
- 510(k) Number
- K221925 FDA UDI
- FDA Product Code
- QWR FDA UDI
- GMDN Term
- SARS-CoV-2 nucleic acid IVD, control 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, control
ID NOW COVID-19 2.0 Control Swab Kit 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, control.
- Aptima® — Hologic, Inc. · Class II
- RealTime — Abbott Molecular · N
- ACCURUN® — LGC Clinical Diagnostics, Inc.
- NATtrol™ — ZeptoMetrix LLC · Class I
- NATtrol™ — ZeptoMetrix LLC · Class I
- Simplexa COVID-19 Direct — DiaSorin Molecular LLC · Class II
- AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome — LGC Clinical Diagnostics, Inc. · Class I
- Exact Diagnostics — Exact Diagnostics · Class I
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 c2bd1acc-dcab-45df-b5b6-ae731f69ce90 34 fields · synced Jun 8, 2026