AccessGUDID - DEVICE: ADVIA® Chemistry Direct Bilirubin_2 DBIL

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry Direct Bilirubin_2 DBIL_2 Reagents
Version or Model: 10341114
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2188390
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414513065
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Bilirubin Direct - ADVIA Chem. - RGT - 4x672 tests

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):	No
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?
53233	Conjugated (direct) bilirubin IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of conjugated (direct) bilirubin in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFM	ENZYMATIC METHOD, BILIRUBIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053132	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
Special Storage Condition, Specify: Do not freeze
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: faecae4d-6bed-4b78-9212-ad69b02a0803
Public Version Date: April 26, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016