Aptiva® Celiac Disease IgG Controls - The Celiac Disease IgG Controls include - INOVA DIAGNOSTICS, INC.

Duns Number:188354831

Device Description: The Celiac Disease IgG Controls include antibodies to tTG and DGP.1. Aptiva Celiac IgG Con The Celiac Disease IgG Controls include antibodies to tTG and DGP.1. Aptiva Celiac IgG Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives.2. Aptiva Celiac IgG Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives.

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More Product Details

Catalog Number

-

Brand Name

Aptiva® Celiac Disease IgG Controls

Version/Model Number

724102

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

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

Device Record Status

Public Device Record Key

def11927-aac5-4e4a-9545-1771c6b03e36

Public Version Date

June 06, 2022

Public Version Number

1

DI Record Publish Date

May 27, 2022

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