Identity
- Trade Name
- AMYLASE REAGENT SET (KINETIC METHOD) FDA UDI
- Generic Name
- Total amylase IVD, reagent FDA UDI
- Device Name
- The AMYLASE REAGENT SET (KINETIC METHOD) is used for the quantitative kinetic determination of amylase activity, using manual or automated procedures, in human serum and urine. FDA UDI
- Model / Reference
- A533-60 FDA UDI
- Description
- The AMYLASE REAGENT SET (KINETIC METHOD) is used for the quantitative kinetic determination of amylase activity, using manual or automated procedures, in human serum and urine. FDA UDI
Identifiers
- Catalog Number
- A533-60 FDA UDI
- Primary DI / UDI-DI
- 10673486001143 FDA UDI
- 510(k) Number
- K931080 FDA UDI
- FDA Product Code
- JFJ FDA UDI
- GMDN Term
- Total amylase IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1070 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: Total amylase IVD, reagent
Amylase Reagent Set (kinetic Method) by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total amylase IVD, reagent.
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- ACE — Alfa Wassermann, Inc. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- ARCHITECT — Abbott · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA UDI 85c00dec-c8b6-4930-a83c-1335c05983fb 37 fields · synced Jun 1, 2026