Identity
- Trade Name
- JAMES EUDAMEDFDA UDI
- Generic Name
- Multiple Enterobacteriaceae species culture isolate identification IVD, reagent FDA UDI
- Device Name
- JAMES EUDAMEDJAMES is a reagent associated to API® NH, API 20 ETM, API® 10 S, RapiD 20 ETM, API® 20 NE, RAPIDEC® ur, ID 32 E), rapid ID 32 A, rapid ID 32 E FDA UDI
- Model / Reference
- 70542 EUDAMEDFDA UDI
- Description
- JAMES is a reagent associated to API® NH, API 20 ETM, API® 10 S, RapiD 20 ETM, API® 20 NE, RAPIDEC® ur, ID 32 E), rapid ID 32 A, rapid ID 32 E FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026099893 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000139TA 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 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
Yes
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
James 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
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 |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (2)
- FDA UDI ac294ece-8c3c-4000-9504-6311447cf986 34 fields · synced Jul 11, 2026
- EUDAMED 1dfc4159-7c79-4b8e-8e13-355afd241ed5 61 fields · synced Jul 11, 2026