VIDAS® Lyme IgG II - VIDAS Lyme IgG II assay is a qualitative - BIOMERIEUX SA

Duns Number:276816717

Device Description: VIDAS Lyme IgG II assay is a qualitative immunoassay intended for use on VIDAS family ins VIDAS Lyme IgG II assay is a qualitative immunoassay intended for use on VIDAS family instrument in the presumptive detection of human IgG antibodies to Borrelia burgdorferi.

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More Product Details

Catalog Number

-

Brand Name

VIDAS® Lyme IgG II

Version/Model Number

417401

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

K122986

Product Code Details

Product Code

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Device Record Status

Public Device Record Key

5b638fe2-dbde-467e-a519-075b73315679

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMERIEUX SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 156
3 A medical device with high risk that requires premarket approval 3