AIMTAB KETONE TABLETS - Tablet test for the detection of ketones - GERMAINE LABORATORIES, INC

Duns Number:176458115

Device Description: Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine, serum, p Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. Similar to Acetest, trademark used by Bayer Healthcare, LLC.

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More Product Details

Catalog Number

-

Brand Name

AIMTAB KETONE TABLETS

Version/Model Number

13100

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)

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

JIN

Product Code Name

Nitroprusside, Ketones (Urinary, Non-Quant.)

Device Record Status

Public Device Record Key

aa4eb819-4337-4400-98ed-2908efd3cd35

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 27, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GERMAINE LABORATORIES, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 22