Pointe Scientific, Inc. Microalbumin

FDA UDI

Class II (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name: Pointe Scientific, Inc. Microalbumin FDA UDI
Generic Name: Microalbumin IVD, reagent FDA UDI
Device Name: Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination of low levels of albumin in urine by immunoturbidimetric assay. For in vitro diagnostic use. 4 x 20 ml., 2 x 10 ml. FDA UDI
Model / Reference: M7562-100 FDA UDI
Description: Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination of low levels of albumin in urine by immunoturbidimetric assay. For in vitro diagnostic use. 4 x 20 ml., 2 x 10 ml. FDA UDI

Identifiers

Catalog Number: M7562-100 FDA UDI
Primary DI / UDI-DI: 00811727011886 FDA UDI
510(k) Number: K023860 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

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: Microalbumin IVD, reagent

Pointe Scientific, Inc. Microalbumin by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Microalbumin IVD, reagent.

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ClearChem Diagnostics Inc. MicroAlbumin — CLEARCHEM DIAGNOSTICS INC. · Class II
K-ASSAY® Microalbumin Reagent — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
JAS Diagnostics — Drew Scientific , Ltd. · Class II

Cleared under the same submission

K023860 also covers:

Pointe Scientific, Inc. Microalbumin Calibrator — POINTE SCIENTIFIC, INC.

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: Pointe Scientific, Inc.

Sources (1)

FDA UDI 0d34b507-9748-44b4-8c46-e71a67cc81d6 37 fields · synced May 29, 2026