AccessGUDID - DEVICE: CAPI 3 URINE (03607360025130)

GUDID

Device Identifier (DI) Information

Brand Name: CAPI 3 URINE
Version or Model: 2513
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2513
Company Name: SEBIA

Primary DI Number: 03607360025130
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276801933 *Terms of Use

Device Description: CAPILLARYS 3 URINE KIT IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K192095

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):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
53967	Protein electrophoresis IVD, kit, electrophoresis	A collection of reagents and other associated materials intended to be used for determining the qualitative and/or quantitative separation of proteins in a clinical specimen, using an electrophoresis method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEF	Electrophoretic, Protein Fractionation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 30 Degrees Celsius
Special Storage Condition, Specify: THIS WAY UP FRAGILE HANDLE WITH CARE KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4473f13d-2a28-4b46-a55d-b53b1b54dbbe
Public Version Date: December 26, 2022
Public Version Number: 1
DI Record Publish Date: December 16, 2022