InteliQ - InteliQ Immunology Control Level 1 (A human serum - BIO-RAD LABORATORIES, INC.

Duns Number:051624070

Device Description: InteliQ Immunology Control Level 1 (A human serum assayed protein control.)

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More Product Details

Catalog Number

12009941

Brand Name

InteliQ

Version/Model Number

12009941

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

41fc24bd-ec9c-42a8-97da-c804ff9669ac

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

September 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIO-RAD LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 511
2 A medical device with a moderate to high risk that requires special controls. 428
U Unclassified 1