Identity
- Trade Name
- BACT/ALERT® MP FDA UDI
- Generic Name
- Differential/selective broth culture medium IVD FDA UDI
- Device Name
- Mycobacteria Detection bottle for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens. FDA UDI
- Model / Reference
- BACT/ALERT MP FDA UDI
- Description
- Mycobacteria Detection bottle for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026596163 FDA UDI
- 510(k) Number
- K190405 FDA UDI
- FDA Product Code
- MDB FDA UDI
- GMDN Term
- Differential/selective broth culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2560 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
No
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: Differential/selective broth culture medium IVD
Bact/Alert® Mp by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190405 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 I | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI 9d102ca5-894f-4310-a514-2af48f92deeb 35 fields · synced May 30, 2026