KWIK-STIK™ - KWIK-STIK™ B. cenocepacia ATCC BAA-245™ - MICROBIOLOGICS INC.

Duns Number:060467826

Device Description: KWIK-STIK™ B. cenocepacia ATCC BAA-245™

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More Product Details

Catalog Number

01269U

Brand Name

KWIK-STIK™

Version/Model Number

01269U

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

JTR

Product Code Name

KIT, QUALITY CONTROL FOR CULTURE MEDIA

Device Record Status

Public Device Record Key

887a867f-500d-4c14-b2b1-a4f75d0d9126

Public Version Date

May 08, 2020

Public Version Number

1

DI Record Publish Date

April 30, 2020

Additional Identifiers

Package DI Number

30845357042614

Quantity per Package

6

Contains DI Package

10845357042634

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

6 Pack

"MICROBIOLOGICS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1104
2 A medical device with a moderate to high risk that requires special controls. 24