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JAS Diagnostics

FDA UDI

Class II (US FDA UDI)

by Drew Scientific , Ltd.

Identity

Trade Name
JAS Diagnostics FDA UDI
Generic Name
Aspartate aminotransferase (AST) isoenzyme IVD, control FDA UDI
Device Name
AST LIQUID REAGENT (1x 1L) FDA UDI
Model / Reference
AST2-1L FDA UDI
Description
AST LIQUID REAGENT (1x 1L) FDA UDI

Identifiers

Primary DI / UDI-DI
00817274020890 FDA UDI
FDA Product Code
CIT FDA UDI
GMDN Term
Aspartate aminotransferase (AST) isoenzyme IVD, control 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Aspartate aminotransferase (AST) isoenzyme IVD, control

JAS Diagnostics by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Drew Scientific , Ltd.

Sources (1)

  • FDA UDI 6fffc59e-4e7e-454f-bd35-7eece11ba541 35 fields · synced Jun 6, 2026