Hemoglobin A1c Calibrators

FDA UDI

Class I (US FDA UDI)

by Cliniqa Corporation

Identity

Trade Name: Hemoglobin A1c Calibrators FDA UDI
Generic Name: Multiple human hormone IVD, calibrator FDA UDI
Device Name: Hemoglobin A1c Calibrators FDA UDI
Model / Reference: 85962 FDA UDI
Description: Hemoglobin A1c Calibrators FDA UDI

Identifiers

Primary DI / UDI-DI: 00817238010783 FDA UDI
510(k) Number: K922904 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Multiple human hormone IVD, calibrator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
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

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: Multiple human hormone IVD, calibrator

Hemoglobin A1c Calibrators by Cliniqa Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K922904 also covers:

Fructosamine Calibrator — CLINIQA CORPORATION

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: Cliniqa Corporation

Sources (1)

FDA UDI 8597443f-9b10-4d23-9330-c10c91d6115f 34 fields · synced May 30, 2026