FDA.reportPublic FDA data

ACE Kinetic Kit

Primary DI
EBUHKKACK21
Brand
ACE Kinetic Kit
Company
Bühlmann Laboratories AG
Model
KK-ACK2
Catalog number
KK-ACK2
Device description
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.
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQNRadioassay, Angiotensin Converting Enzyme

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQNRadioassay, Angiotensin Converting EnzymeClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913091000BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAYAmerican Laboratory Products Co., Ltd.1991-08-26KQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBUHKKACK21PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Angiotensin converting enzyme (ACE) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of angiotensin converting enzyme (ACE) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(844) 300-9799info@buhlmannlabs.com

Regulatory Flags#

DUNS number
481261006
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EBUHBKPELARSET0BÜHLMANN fPELA® turbo Reagent KitB-KPELA-RSET2020-06-22
EBUHKKACK20BÜHLMANN ACE KineticKK-ACK2KK-ACK22025-06-27
EBUHBCCRLYR20CAST® Lysing Reagent BasophilB-CCR-LYR202025-03-04
EBUHBCCRSR20CAST® Staining Reagent BasophilB-CCR-SR202025-03-04
EBUHBCCRSTB5CAST® Stimulation Buffer BasophilB-CCR-STB52025-03-04
EBUHBCCRSTCON10CAST® Stimulation Control BasophilB-CCR-STCON102025-03-04
EBUHBCCRWB10CAST® Wash Buffer BasophilB-CCR-WB102025-03-04
EBUHBKCALRSETUS0BÜHLMANN fCAL® turbo Reagent KitB-KCAL-RSET-US2023-05-02
04260714340007fCAL turbo089103671902022-06-13
EBUHBCALSAMPLER250Simple Sampler Stool Collection SetB-CAL-SAMPLER252023-06-26
EBUHBKPELACONSET0BÜHLMANN fPELA® turbo Control KitB-KPELA-CONSET2020-06-22
EBUHKPELACASET0BÜHLMANN fPELA® turbo Calibrator KitB-KPELA-CASET2020-06-22
07613336169926fCAL turbo089103321902020-05-27
EBUH089104991900fCAL Calibrator Set089104991902020-05-27
EBUHBEKCAL0BÜHLMANN fCAL® ELISAEK-CAL2019-11-06
EBUHBEKCAL20BÜHLMANN fCAL® ELISAEK-CAL22019-11-06
EBUHBKCALCASET0BÜHLMANN fCAL® turbo Calibrator KitB-KCAL-CASET2019-11-01
EBUHBKCALRSET0BÜHLMANN fCAL® turbo Reagent KitB-KCAL-RSET2019-11-01
EBUHBIPOCTRABS0Quantum Blue® ReaderBI-POCTR-ABS2021-01-12
EBUH089109870010CALEX Cap089109870012020-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EBUHKKACK20BÜHLMANN ACE KineticBühlmann Laboratories AGKQN2025-06-27
08058056685308ACE ReagentSENTINEL CH. SPAKQN2025-01-27
08058056685339ACE ReagentSENTINEL CH. SPAKQN2025-01-27
06971674866831BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
06971674866848BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
06971674866855BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
06971674867852BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
06971674868361BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
05391516746014Trinity BiotechTRINITY BIOTECH PUBLIC LIMITED COMPANYKQN2016-09-23
EBUHKKACK1ACE Kinetik KitBühlmann Laboratories AGKQN2016-09-01
EBUHKKACK41ACE Kinetic KitBühlmann Laboratories AGKQN2016-09-01
EBUHKKACKX1ACE Kinetic KitBühlmann Laboratories AGKQN2016-09-01
08058056681751ACE LiquidSENTINEL CH. SPAKQN2016-07-29