AccessGUDID - DEVICE: ACTIVE RENIN (03661541510518)

GUDID

Device Identifier (DI) Information

Brand Name: ACTIVE RENIN
Version or Model: RENIN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RENIN
Company Name: CISBIO BIOASSAYS

Primary DI Number: 03661541510518
Issuing Agency: GS1
Commercial Distribution End Date: December 06, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 261769626 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
54348	Renin IVD, kit, radioimmunoassay	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIB	Radioimmunoassay, Angiotensin I And Renin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062120	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 100 tests

Device Record Status

Public Device Record Key: 84b11076-e43d-4eb7-891c-b26db17ef93b
Public Version Date: December 08, 2021
Public Version Number: 4
DI Record Publish Date: August 08, 2016