RaPET® s-LE - Latex Agglutination Slide Test for the Detection - STANBIO LABORATORY, L.P.

Duns Number:045361136

Device Description: Latex Agglutination Slide Test for the Detection and Quantitation of serum antinucleoprote Latex Agglutination Slide Test for the Detection and Quantitation of serum antinucleoprotein factors associated with systemic Lupus Erythematosis in Human Serum.

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More Product Details

Catalog Number

1160-050

Brand Name

RaPET® s-LE

Version/Model Number

1160-050

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 01, 2019

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

Yes

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

LJM

Product Code Name

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Device Record Status

Public Device Record Key

f40aa357-0d8b-4b3e-b03b-b75075660706

Public Version Date

February 04, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STANBIO LABORATORY, L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 69
2 A medical device with a moderate to high risk that requires special controls. 86