AccessGUDID - DEVICE: IDS-iSYS Direct Renin (05060169690707)

GUDID

Device Identifier (DI) Information

Brand Name: IDS-iSYS Direct Renin
Version or Model: IS-4800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMMUNODIAGNOSTIC SYSTEMS LIMITED

Primary DI Number: 05060169690707
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 494268600 *Terms of Use

Device Description: No description.

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:	Yes
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):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
54347	Renin IVD, reagent	A 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 renin (direct, active, or immunoreactive) in a clinical specimen.	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 [?]
K123763	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Prior to first use. Store the cartridge and calibrators in an upright position in the dark. Do not freeze the cartridge

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d05ba91-130d-40e3-b490-a37ef4825b95
Public Version Date: December 19, 2022
Public Version Number: 4
DI Record Publish Date: April 01, 2016