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ClearChem Diagnostics Inc. Aspartate aminotransferase (AST)

FDA UDI

Class II (US FDA UDI)

by Clearchem Diagnostics Inc.

Identity

Trade Name
ClearChem Diagnostics Inc. Aspartate aminotransferase (AST) FDA UDI
Generic Name
Aspartate aminotransferase (AST) isoenzyme IVD, reagent FDA UDI
Device Name
In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL FDA UDI
Model / Reference
AST1040 FDA UDI
Description
In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL FDA UDI

Identifiers

Catalog Number
AST1040 FDA UDI
Primary DI / UDI-DI
00852169008058 FDA UDI
FDA Product Code
CIT FDA UDI
GMDN Term
Aspartate aminotransferase (AST) isoenzyme IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 225 Milliliter FDA UDI

Category: Aspartate aminotransferase (AST) isoenzyme IVD, reagent

ClearChem Diagnostics Inc. Aspartate aminotransferase (AST) by Clearchem Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Aspartate aminotransferase (AST) isoenzyme IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clearchem Diagnostics Inc.

Sources (1)

  • FDA UDI 3c851b07-d1e1-4d04-bbc0-90f07f413c33 37 fields · synced May 29, 2026