ClearChem Diagnostics Inc. MicroAlbumin

FDA UDI

Class II (US FDA UDI)

by Clearchem Diagnostics Inc.

Identity

Trade Name: ClearChem Diagnostics Inc. MicroAlbumin FDA UDI
Generic Name: Microalbumin IVD, reagent FDA UDI
Device Name: In Vitro Diagnostics testing kit R1:4X20mL, R2:2X10mL FDA UDI
Model / Reference: MAL1010 FDA UDI
Description: In Vitro Diagnostics testing kit R1:4X20mL, R2:2X10mL FDA UDI

Identifiers

Catalog Number: MAL1010 FDA UDI
Primary DI / UDI-DI: 00852169008270 FDA UDI
FDA Product Code: JIT FDA UDI
DDZ FDA UDI
GMDN Term: Microalbumin IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 FDA UDI
866.5040 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 — 100 Milliliter FDA UDI

Category: Microalbumin IVD, reagent

ClearChem Diagnostics Inc. MicroAlbumin by Clearchem Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microalbumin IVD, reagent.

Alere Afinion™ ACR — Abbott Diagnostics Technologies AS · Class II
K-ASSAY® Microalbumin Reagent (L) — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
Afinion ACR — Abbott Diagnostics Technologies AS · Class II
Pointe Scientific, Inc. Microalbumin — POINTE SCIENTIFIC, INC. · Class II
K-ASSAY® Microalbumin Reagent — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
JAS Diagnostics — Drew Scientific , Ltd. · 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	Class II	Pending data

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Manufacturer

Manufacturer: Clearchem Diagnostics Inc.

Sources (1)

FDA UDI 30e60822-e009-47d8-b037-2b8c2c16aea9 37 fields · synced May 30, 2026