P Amy

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: P AMY FDA UDI
Generic Name: Amylase isoenzyme IVD, reagent FDA UDI
Device Name: A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro determination of Pancreatic α‑Amylase activity in serum, plasma or urine. FDA UDI
Model / Reference: AY3855 FDA UDI
Description: A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro determination of Pancreatic α‑Amylase activity in serum, plasma or urine. FDA UDI

Identifiers

Catalog Number: AY3855 FDA UDI
Primary DI / UDI-DI: 05055273200614 FDA UDI
510(k) Number: K971825 FDA UDI
FDA Product Code: JFJ 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Amylase isoenzyme IVD, reagent

P 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
AMY — Randox Laboratories, Ltd. · Class II
AMY — Randox Laboratories, Ltd. · Class II
AMY — Randox Laboratories, Ltd. · Class II

Cleared under the same submission

K971825 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

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Manufacturer

Manufacturer: Randox Laboratories, Ltd.

Sources (1)

FDA UDI 8a7dc279-badb-4237-a3f5-b242cc63be38 37 fields · synced Jun 1, 2026