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Active Renin

FDA UDI

Class II (US FDA UDI)

by Cisbio Bioassays

Identity

Trade Name
ACTIVE RENIN FDA UDI
Generic Name
Renin IVD, kit, radioimmunoassay FDA UDI
Device Name
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. FDA UDI
Model / Reference
RENIN FDA UDI
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. FDA UDI

Identifiers

Catalog Number
RENIN FDA UDI
Primary DI / UDI-DI
03661541510518 FDA UDI
510(k) Number
K062120 FDA UDI
FDA Product Code
CIB FDA UDI
GMDN Term
Renin IVD, kit, radioimmunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1085 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

Yes

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Active Renin by Cisbio Bioassays — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cisbio Bioassays

Sources (1)

  • FDA UDI 84b11076-e43d-4eb7-891c-b26db17ef93b 39 fields · synced May 30, 2026