Creatinine/ Endpoint

FDA UDI

by Sterling Diagnostics Inc

Identity

Trade Name: CREATININE/ ENDPOINT FDA UDI
Generic Name: Creatinine IVD, reagent FDA UDI
Device Name: CREATININE/ENDPOINT FDA UDI
Model / Reference: 2167-0 FDA UDI
Description: CREATININE/ENDPOINT FDA UDI

Identifiers

Catalog Number: 2167-0 FDA UDI
Primary DI / UDI-DI: 00852223007041 FDA UDI
GMDN Term: Creatinine IVD, reagent FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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: Creatinine IVD, reagent

Creatinine/ Endpoint by Sterling Diagnostics Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Creatinine IVD, reagent.

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Electrode for ABL analyzers — Radiometer Medical ApS · Class II
Teco Diagnostics Creatinine (Kinetic) Reagent Kit TC-MATRIX-240/480 — TECO DIAGNOSTICS · Class II
Piccolo Comprehensive Metabolic Panel — ABAXIS, INC. · Class II
ClearChem Diagnostics Inc. Creatinine (Jaffe) — CLEARCHEM DIAGNOSTICS INC. · Class II
Alinity — Abbott Laboratories, Inc. · Class II
Alinity — Abbott Laboratories, Inc. · 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	N/A	Pending data

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Manufacturer

Manufacturer: Sterling Diagnostics Inc

Sources (1)

FDA UDI b63cc262-06ba-4dd7-9225-379f53c7797d 34 fields · synced May 30, 2026