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Pointe Scientific

FDA UDI

Class II (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name
Pointe Scientific FDA UDI
Generic Name
Aspartate aminotransferase (AST) isoenzyme IVD, reagent FDA UDI
Device Name
AST Reagent Set for the quantitative determination of Aspartate Aminotransferase (AST) in human serum. Packaged at 5 x 100ml, 2 x 55ml FDA UDI
Model / Reference
HA961-610 FDA UDI
Description
AST Reagent Set for the quantitative determination of Aspartate Aminotransferase (AST) in human serum. Packaged at 5 x 100ml, 2 x 55ml FDA UDI

Identifiers

Catalog Number
HA961-610 FDA UDI
Primary DI / UDI-DI
00811727012555 FDA UDI
510(k) Number
K813405 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Category: Aspartate aminotransferase (AST) isoenzyme IVD, reagent

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

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
Pointe Scientific, Inc.

Sources (1)

  • FDA UDI b766b3dc-b90f-4f2f-b849-6ee0d7009c65 37 fields · synced Jun 8, 2026