Identity
- Trade Name
- ALT EUDAMEDAU FDA UDI
- Generic Name
- Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- ALT EUDAMEDFDA UDI
- Model / Reference
- OSR6607 EUDAMEDFDA UDI
- Description
- ALT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590060022 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995901OSR6607MS EUDAMED
- 510(k) Number
- K925339 FDA UDI
- FDA Product Code
- CKA FDA UDI
- EMDN Code
- W01010103 ALANINE AMINO-TRANSFERASE EUDAMED
- GMDN Term
- Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1030 FDA UDI
- Market of Registration
- Ireland 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
Yes
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Alanine aminotransferase (ALT) IVD, reagent
Alt by Beckman Coulter, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alanine aminotransferase (ALT) IVD, reagent.
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- Alinity — Abbott · Class I
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 | 150995901OSR6607MS | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Inc.
- EUDAMED SRN
- US-MF-000010288
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (2)
- EUDAMED abf7d267-b737-4dd2-bd98-08042deabe9a 61 fields · synced Jun 18, 2026
- FDA UDI 9e2b7a13-ee08-491e-b362-401624bf474c 34 fields · synced May 30, 2026