Identity
- Trade Name
- ALT (SGPT) REAGENT SET (UV-KINETIC METHOD) FDA UDI
- Generic Name
- Alanine aminotransferase (ALT) IVD, reagent FDA UDI
- Device Name
- The ALT (SGPT) REAGENT SET (UV-KINETIC METHOD) is used for the quantitative determination of alanine aminotransferase in human serum. FDA UDI
- Model / Reference
- A525-400 FDA UDI
- Description
- The ALT (SGPT) REAGENT SET (UV-KINETIC METHOD) is used for the quantitative determination of alanine aminotransferase in human serum. FDA UDI
Identifiers
- Catalog Number
- A525-400 FDA UDI
- Primary DI / UDI-DI
- 10673486001112 FDA UDI
- 510(k) Number
- K864906 FDA UDI
- FDA Product Code
- CKA FDA UDI
- GMDN Term
- Alanine aminotransferase (ALT) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Category: Alanine aminotransferase (ALT) IVD, reagent
Alt (sgpt) Reagent Set (uv-Kinetic Method) by Teco Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K864906 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA UDI 781be17a-eb03-4bae-8adc-61a115a0b102 37 fields · synced May 30, 2026