i-STAT - i-STAT 1 Analyzer, Immuno Ready - ABBOTT POINT OF CARE INC.

Duns Number:079226216

Device Description: i-STAT 1 Analyzer, Immuno Ready

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More Product Details

Catalog Number

04P75-40

Brand Name

i-STAT

Version/Model Number

04P75-40

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)

-

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

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Device Record Status

Public Device Record Key

93cbeea7-c4da-4e73-b507-d26e6b5c770b

Public Version Date

June 22, 2020

Public Version Number

3

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 POINT OF CARE INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 42
3 A medical device with high risk that requires premarket approval 14