ACE Kinetic Kit KK-ACK4

GUDID EBUHKKACK41

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.

Bühlmann Laboratories AG

Angiotensin converting enzyme (ACE) IVD, reagent
Primary Device IDEBUHKKACK41
NIH Device Record Key0ad56d2f-f422-4f63-917f-6ee5ef2fa787
Commercial Distribution StatusIn Commercial Distribution
Brand NameACE Kinetic Kit
Version Model NumberKK-ACK4
Catalog NumberKK-ACK4
Company DUNS481261006
Company NameBühlmann Laboratories AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(844) 300-9799
Emailinfo@buhlmannlabs.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEBUHKKACK41 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KQNRadioassay, Angiotensin Converting Enzyme

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

On-Brand Devices [ACE Kinetic Kit]

EBUHKKACKX1The BÜHLMANN ACE kinetic test is intended for the direct and quantitative in vitro diagnost
EBUHKKACK41The BÜHLMANN ACE kinetic test is intended for the direct and quantitative in vitro diagnost
EBUHKKACK21The BÜHLMANN ACE kinetic test is intended for the direct and quantitative in vitro diagnost

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