AccessGUDID - DEVICE: Bilirubin Total Gen.3 (07613336235508)

GUDID

Device Identifier (DI) Information

Brand Name: Bilirubin Total Gen.3
Version or Model: 10421410190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10421410190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336235508
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
53229	Total bilirubin IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total bilirubin in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIG	DIAZO COLORIMETRY, BILIRUBIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131544	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4e90cb61-3d96-49c2-919c-cc8baf01ba13
Public Version Date: February 12, 2025
Public Version Number: 1
DI Record Publish Date: February 04, 2025