NOVA Gel® Jo-1 “T” Extractable Nuclear Autoantibody Reagents - 1. 8 prepunched NOVA Gel titering “T” plates2. 2 - INOVA DIAGNOSTICS, INC.

Duns Number:188354831

Device Description: 1. 8 prepunched NOVA Gel titering “T” plates2. 2 0.4mL Jo-1 antigen, lyophilized3. 1 1.4mL 1. 8 prepunched NOVA Gel titering “T” plates2. 2 0.4mL Jo-1 antigen, lyophilized3. 1 1.4mL Jo-1 Control

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More Product Details

Catalog Number

-

Brand Name

NOVA Gel® Jo-1 “T” Extractable Nuclear Autoantibody Reagents

Version/Model Number

708495

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 02, 2018

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

LLL

Product Code Name

Extractable Antinuclear Antibody, Antigen And Control

Device Record Status

Public Device Record Key

445c7b06-ad37-4c41-afb7-0b5e5f97239e

Public Version Date

March 08, 2022

Public Version Number

4

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

-

"INOVA DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 215