FDA.reportPublic FDA data

Angiotensin II RIA

Primary DI
EBUHRKA221
Brand
Angiotensin II RIA
Company
Bühlmann Laboratories AG
Model
RK-A22
Catalog number
RK-A22
Device description
The BÜHLMANN Angiotensin II is a double antibody radioimmunoassay designed for the quantitative in vitro diagnostic determination of immunoreactive Angiotensin II in extracted EDTA plasma.
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
CIBRadioimmunoassay, Angiotensin I And Renin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIBRadioimmunoassay, Angiotensin I And ReninClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954299000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954299000BUHLMANN ANGIOSTENSIN II RIABuhlmann Laboratories AG1995-10-19CIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBUHRKA221PrimaryHIBCC0

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
EBUHKKACK21ACE Kinetic KitKK-ACK2KK-ACK22016-09-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770024321319ACTIVE RENINCISBIO BIOASSAYSCIB2021-12-07
03661541510518ACTIVE RENINCISBIO BIOASSAYSCIB2016-08-08
05060169690707IDS-iSYS Direct Renin IMMUNODIAGNOSTIC SYSTEMS LIMITEDCIB2016-04-01