Identity
- Trade Name
- ID color Catalase EUDAMEDAPI® ID-ASE FDA UDI
- Generic Name
- Catalase production microbial reagent IVD FDA UDI
- Device Name
- ID color Catalase EUDAMEDManual reagent for catalase test. API®strips give accurate identifications based on extensive databases and are standardized, easy-to-use test systems. FDA UDI
- Model / Reference
- 540609 EUDAMEDAPI® ID-ASE FDA UDI
- Description
- Manual reagent for catalase test. API®strips give accurate identifications based on extensive databases and are standardized, easy-to-use test systems. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026584139 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000490TR EUDAMED
- FDA Product Code
- JTO FDA UDI
- EMDN Code
- W0104080208 SINGLE TESTS (DISCS, STRIPS, DROPPERS...) EUDAMED
- GMDN Term
- Catalase production microbial reagent IVD 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
No
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
Category: Catalase production microbial reagent IVD
Api® Id-Ase by Biomerieux , Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Catalase production microbial reagent IVD.
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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 8b661a60-e65a-4aa9-90df-763ced591d95 34 fields · synced Jul 8, 2026
- EUDAMED 2c327dfa-c665-4e6d-a487-00fd0dc9a1f4 61 fields · synced Jun 18, 2026