FDA.reportPublic FDA data

ACTIVE RENIN

Primary DI
03770024321319
Brand
ACTIVE RENIN
Company
CISBIO BIOASSAYS
Model
RENIN
Catalog number
RENIN
Device description
Radioimmunometric assay kit for the quantitative determination of active renin in human plasma.Contains enough reagents for 100 tests. For in vitro diagnostic.Quantitative determination of active renin is used in the diagnostic and treatment of certain types of hypertensions.
Published
2021-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K062120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062120000CISBIO RENIN RIA TESTCis Bio International2007-03-30CIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770024321319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770024321319037700243213193770024321319

GMDN Terms#

Term, Definition table
TermDefinition
Renin IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of renin (direct, active, or immunoreactive) in a clinical specimen, using a radioimmunoassay method. It is used to aid in the diagnosis of certain forms of hypertension.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33466796700iva@cisbio.com

Regulatory Flags#

DUNS number
261769626
Device count
1
HCT/P
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770024321562HGH-USHGH-USHGH-US2021-12-07
03770024321579TRYPS-USTRYPS-USTRYPS-US2021-12-07
03770024321586ESTR-S-USESTR-S-USESTR-S-US2021-12-07
03770024321593ESTR-USESTR-USESTR-US2021-12-07
03770024321609PROGEST-USPROGEST-USPROGEST-US2021-12-07
03661541510518ACTIVE RENINRENINRENIN2016-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EBUHRKA221Angiotensin II RIABühlmann Laboratories AGCIB2016-09-01
03661541510518ACTIVE RENINCISBIO BIOASSAYSCIB2016-08-08
05060169690707IDS-iSYS Direct Renin IMMUNODIAGNOSTIC SYSTEMS LIMITEDCIB2016-04-01