ARCHITECT - Aspartate Aminotransferase - ABBOTT LABORATORIES

Duns Number:079226220

Device Description: Aspartate Aminotransferase

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More Product Details

Catalog Number

07D8121

Brand Name

ARCHITECT

Version/Model Number

7D81-21

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CIT

Product Code Name

Nadh oxidation/nad reduction, ast/sgot

Device Record Status

Public Device Record Key

9a092109-f9c3-4dbc-9b00-b3f9d7628a56

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT LABORATORIES" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 259
2 A medical device with a moderate to high risk that requires special controls. 245
U Unclassified 5