CARDINAL HEALTH - Cardinal Health; Crypto Giardia Control; Contains - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Cardinal Health; Crypto Giardia Control; Contains (1) 1.0mL Cryptosporidium + and (1) 1.0 Cardinal Health; Crypto Giardia Control; Contains (1) 1.0mL Cryptosporidium + and (1) 1.0mL Giardia +; IVD

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More Product Details

Catalog Number

CH6870

Brand Name

CARDINAL HEALTH

Version/Model Number

CH6870

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JTR

Product Code Name

KIT, QUALITY CONTROL FOR CULTURE MEDIA

Device Record Status

Public Device Record Key

85ecf88a-0bde-485d-b32d-54c03129e42e

Public Version Date

August 29, 2022

Public Version Number

3

DI Record Publish Date

December 27, 2018

Additional Identifiers

Package DI Number

50885380096745

Quantity per Package

64

Contains DI Package

20885380096744

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40