AccessGUDID - DEVICE: Total Bilirubin (00811727013583)

GUDID

Device Identifier (DI) Information

Brand Name: Total Bilirubin
Version or Model: 12-HB979-192
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12-HB979-192
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727013583
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: For the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.

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?
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 [?]
K040391	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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0d9412f6-96d0-482c-bb7b-7dd6d4593c2f
Public Version Date: July 06, 2023
Public Version Number: 4
DI Record Publish Date: August 31, 2016