Identity
- Trade Name
- AMY FDA UDI
- Generic Name
- Amylase isoenzyme IVD, reagent FDA UDI
- Device Name
- An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine. FDA UDI
- Model / Reference
- AY3805 FDA UDI
- Description
- An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine. FDA UDI
Identifiers
- Catalog Number
- AY3805 FDA UDI
- Primary DI / UDI-DI
- 05055273200607 FDA UDI
- 510(k) Number
- K953211 FDA UDI
- FDA Product Code
- CIJ FDA UDI
- GMDN Term
- Amylase isoenzyme 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
Yes
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: Amylase isoenzyme IVD, reagent
Amy by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amylase isoenzyme IVD, reagent.
- AMYLASE (CNPG3) Reagent Set — CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Class II
- Pancreatic Amylase — Sentinel Ch. Srl · Class II
- ClearChem Diagnostics Inc. Amylase — CLEARCHEM DIAGNOSTICS INC. · Class II
- Thermo Scientific Infinity™ — Fisher Diagnostics · Class II
- AMY — Randox Laboratories, Ltd. · Class II
- P AMY — Randox Laboratories, Ltd. · Class II
- AMY — Randox Laboratories, Ltd. · Class II
- AMY — Randox Laboratories, Ltd. · Class II
Cleared under the same submission
K953211 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 26dc299d-fe09-4767-8027-f00c630c3952 37 fields · synced May 30, 2026