Identity
- Trade Name
- API® NaCl 0.85% Medium FDA UDI
- Generic Name
- Multiple Enterobacteriaceae species culture isolate identification IVD, reagent FDA UDI
- Device Name
- NaCl 0.85 % Medium and Suspension Medium are designed to be used as suspension media with API ®, ID 32 or ATB™ products. FDA UDI
- Model / Reference
- API® NaCL 0.85% Medium, 2 ml FDA UDI
- Description
- NaCl 0.85 % Medium and Suspension Medium are designed to be used as suspension media with API ®, ID 32 or ATB™ products. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026588472 FDA UDI
- FDA Product Code
- JTO FDA UDI
- GMDN Term
- Multiple Enterobacteriaceae species culture isolate identification IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
Yes
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 Enterobacteriaceae species culture isolate identification IVD, reagent
API® NaCl 0.85% Medium by Biomerieux , Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (2)
- FDA UDI 8a589a3d-6944-434a-b23a-e7f056078162 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026