Identity
- Trade Name
- BinaxNOW® Malaria Positive Control Kit FDA UDI
- Generic Name
- Multiple Plasmodium species antigen IVD, control FDA UDI
- Device Name
- The BinaxNOW® Malaria Positive Control. FDA UDI
- Model / Reference
- 665-010 FDA UDI
- Description
- The BinaxNOW® Malaria Positive Control. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877010712 FDA UDI
- 510(k) Number
- K083744 FDA UDI
- FDA Product Code
- MJZ FDA UDI
- GMDN Term
- Multiple Plasmodium species antigen IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
No
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: Multiple Plasmodium species antigen IVD, control
BinaxNOW® Malaria Positive Control Kit by Alere Scarborough, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI f02a5718-363d-4c18-b5d3-6022eb6b9f55 34 fields · synced May 30, 2026