Identity
- Trade Name
- API® Staph EUDAMEDFDA UDI
- Generic Name
- Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit FDA UDI
- Device Name
- API® Staph EUDAMEDAPI® Staph is a standardized system for the identification of the genera Staphylococcus, Micrococcus and Kocuria FDA UDI
- Model / Reference
- 20500 EUDAMEDFDA UDI
- Description
- API® Staph is a standardized system for the identification of the genera Staphylococcus, Micrococcus and Kocuria FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026048259 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000039T5 EUDAMED
- FDA Product Code
- JWX FDA UDI
- EMDN Code
- W0104080203 GRAM POSITIVE - MANUAL IDENTIFICATION EUDAMED
- GMDN Term
- Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Yes
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® Staph by Biomerieux Sa — Class B — 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 | 357302BUDI000039T5 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- bioMérieux SA
- EUDAMED SRN
- FR-MF-000004436
Sources (2)
- EUDAMED efb20740-50f0-4578-8084-58f54d569dcf 61 fields · synced Jul 26, 2026
- FDA UDI 1591efb7-2670-46db-9293-f0cddfe0c46f 34 fields · synced May 30, 2026