Identity
- Trade Name
- ID NOW™ COVID-19 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 product. Refer to the ID NOW COVID-19 Product Insert for instructions for use. Contents: 12 Positive Control Swabs, 12 Negative Control Swabs FDA UDI
- Model / Reference
- 190-080 FDA UDI
- Description
- Control Swabs intended for use only with the ID NOW™ COVID-19 product. Refer to the ID NOW COVID-19 Product Insert for instructions for use. Contents: 12 Positive Control Swabs, 12 Negative Control Swabs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877011276 FDA UDI
- FDA Product Code
- QJR FDA UDI
- GMDN Term
- SARS-CoV-2 nucleic acid IVD, control 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 Control Swab Kit 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI af653868-e134-402a-b296-eb77964f4686 34 fields · synced May 29, 2026