ABBOTT PRISM - ABBOTT PRISM Chagas Assay Kit - ABBOTT LABORATORIES

Duns Number:079226220

Device Description: ABBOTT PRISM Chagas Assay Kit

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More Product Details

Catalog Number

07K3568

Brand Name

ABBOTT PRISM

Version/Model Number

7K35-68

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

17796895-4bf5-4e3b-9810-2ce302f7107a

Public Version Date

January 13, 2022

Public Version Number

6

DI Record Publish Date

January 31, 2015

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