Alinity - Alinity i Anti-HBc Reagent Kit 1200 Tests - Abbott GmbH

Duns Number:315786293

Device Description: Alinity i Anti-HBc Reagent Kit 1200 Tests

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More Product Details

Catalog Number

07P8431

Brand Name

Alinity

Version/Model Number

07P8431

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

P080023,P080023,P080023,P080023

Product Code Details

Product Code

LOM

Product Code Name

Test, hepatitis b (b core, be antigen, be antibody, b core igm)

Device Record Status

Public Device Record Key

5d075c27-644c-4432-bc7e-9a45126d842a

Public Version Date

May 07, 2021

Public Version Number

7

DI Record Publish Date

October 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 185
3 A medical device with high risk that requires premarket approval 13