ClearChem Diagnostics Inc. Creatine Kinase (CK)

FDA UDI

Class II (US FDA UDI)

by Clearchem Diagnostics Inc.

Identity

Trade Name: ClearChem Diagnostics Inc. Creatine Kinase (CK) FDA UDI
Generic Name: Total creatine kinase (CK) IVD, reagent FDA UDI
Device Name: In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL FDA UDI
Model / Reference: CPK1110 FDA UDI
Description: In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL FDA UDI

Identifiers

Catalog Number: CPK1110 FDA UDI
Primary DI / UDI-DI: 00852169008089 FDA UDI
FDA Product Code: CGS FDA UDI
GMDN Term: Total creatine kinase (CK) IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1215 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

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

Dimensions & Sizes

Size: Total Volume — 225 Milliliter FDA UDI

Category: Total creatine kinase (CK) IVD, reagent

ClearChem Diagnostics Inc. Creatine Kinase (CK) by Clearchem Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Clearchem Diagnostics Inc.

Sources (1)

FDA UDI cbc2a7e9-2802-4757-93ec-38f70eb09a5a 37 fields · synced Jun 6, 2026