ACE Kinetic Kit - The BÜHLMANN ACE kinetic test is intended for the - Bühlmann Laboratories AG

Duns Number:481261006

Device Description: The BÜHLMANN ACE kinetic test is intended for the direct and quantitative in vitro dia The BÜHLMANN ACE kinetic test is intended for the direct and quantitative in vitro diagnostic determination of angiotensin converting enzyme (ACE) activity in serum by an enzymatic assay.

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More Product Details

Catalog Number

KK-ACK4

Brand Name

ACE Kinetic Kit

Version/Model Number

KK-ACK4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K913091

Product Code Details

Product Code

KQN

Product Code Name

Radioassay, Angiotensin Converting Enzyme

Device Record Status

Public Device Record Key

0ad56d2f-f422-4f63-917f-6ee5ef2fa787

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BÜHLMANN LABORATORIES AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8