ANA Test Kit - Antinuclear Antibody (ANA) Test Kit - ANTIBODIES INCORPORATED

Duns Number:048944128

Device Description: Antinuclear Antibody (ANA) Test Kit

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More Product Details

Catalog Number

15-123

Brand Name

ANA Test Kit

Version/Model Number

15-123

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

Yes

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

DHN

Product Code Name

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Device Record Status

Public Device Record Key

9653da2a-41cd-4d58-a40b-8d80b1ddea14

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANTIBODIES INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4