Identity
- Trade Name
- API® NaCl 0.85% Medium EUDAMEDFDA UDI
- Generic Name
- Multiple Enterobacteriaceae species culture isolate identification IVD, reagent FDA UDI
- Device Name
- API® NaCl 0.85% Medium EUDAMEDNaCl 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
- 541047 EUDAMED541042 EUDAMEDAPI® NaCl 0.85% Medium FDA UDIAPI® NaCl 0.85 % Medium 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
- 03573026588519 EUDAMEDFDA UDI03573026588465 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000213SV EUDAMED
- FDA Product Code
- JTO FDA UDI
- EMDN Code
- W0104080299 MANUAL IDENTIFICATION - OTHER EUDAMED
- GMDN Term
- Multiple Enterobacteriaceae species culture isolate identification IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2660 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
API® NaCl 0.85% Medium by Biomerieux Sa — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 357302BUDI000213SV | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- bioMérieux SA
- EUDAMED SRN
- FR-MF-000004436
Sources (4)
- EUDAMED 83170161-023d-44bf-8a46-9cef19500433 61 fields · synced Jul 26, 2026
- FDA UDI 75bf1f60-40cc-4743-a4d8-89be25702135 34 fields · synced May 29, 2026
- FDA UDI 2e1e5ddb-fa98-4e3d-895c-2f2c6b2f1a09 34 fields · synced May 30, 2026
- EUDAMED 28af7f79-de77-4a50-baa8-76975e92b28b 61 fields · synced Jul 26, 2026