Identity
- Trade Name
- Alere™ PBP2a SA Culture Colony Test FDA UDI
- Generic Name
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit FDA UDI
- Device Name
- A rapid test for the qualitative detection of PBP2a in Staphylococcus aureus isolates. FDA UDI
- Model / Reference
- 893-000 FDA UDI
- Description
- A rapid test for the qualitative detection of PBP2a in Staphylococcus aureus isolates. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877010842 FDA UDI
- 510(k) Number
- K133851 FDA UDI
- FDA Product Code
- MYI FDA UDI
- GMDN Term
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1640 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Alere™ PBP2a SA Culture Colony Test by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K133851 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 |
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Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI dbc82f81-b0e2-4587-afba-1eab4da62a7f 35 fields · synced Jun 8, 2026