Identity
- Trade Name
- Zn EUDAMEDFDA UDI
- Generic Name
- Multiple Enterobacteriaceae species culture isolate identification IVD, reagent FDA UDI
- Device Name
- Zn EUDAMEDZn is a reagent associated to API 20 E® (20 100) API 20 NE® (20 050) API 50 CH® (50 300) API 50 CHB/E® (50 430) FDA UDI
- Model / Reference
- 541069 EUDAMEDZn FDA UDI
- Description
- Zn is a reagent associated to API 20 E® (20 100) API 20 NE® (20 050) API 50 CH® (50 300) API 50 CHB/E® (50 430) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026588731 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000132SU EUDAMED
- FDA Product Code
- JTO FDA UDI
- EMDN Code
- W0104080599 MANUAL SUSCEPTIBILITY TESTING - OTHER EUDAMED
- GMDN Term
- Multiple Enterobacteriaceae species culture isolate identification IVD, reagent FDA UDI
Classification
- Device Class
- Class B 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple Enterobacteriaceae species culture isolate identification IVD, reagent
Zn by Biomerieux , Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multiple Enterobacteriaceae species culture isolate identification IVD, reagent.
- API® NaCl 0.85% Medium — BIOMERIEUX , INC. · Class I
- NIT 1 + NIT 2 — BIOMERIEUX , INC. · Class I
- VP 1 + VP 2 — BIOMERIEUX , INC. · Class I
- TDA — BIOMERIEUX , INC. · Class I
- JAMES — BIOMERIEUX , INC. · Class I
- API® M Medium — BIOMERIEUX , INC. · Class I
- API® 50 CHB/E Medium — BIOMERIEUX , INC. · Class I
- API® Suspension Medium — BIOMERIEUX , INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (2)
- FDA UDI 2fcd374e-4582-475d-b12a-3a1d572ca59a 34 fields · synced Jun 18, 2026
- EUDAMED 48ce0246-f26c-4213-ac54-2ebf61699be4 61 fields · synced Jun 18, 2026