β-Hydroxybutyrate 21 FS - For the quantitative determination of - DiaSys Diagnostic Systems GmbH

Duns Number:328419718

Device Description: For the quantitative determination of beta-hydroxybutyrate in human serum or plasma.

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More Product Details

Catalog Number

137119943018

Brand Name

β-Hydroxybutyrate 21 FS

Version/Model Number

137119943018

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)

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

8f6c5c34-0279-4eff-8e26-16588b337303

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIASYS DIAGNOSTIC SYSTEMS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 1