AccessGUDID - DEVICE: Pointe Scientfic, Inc. (00811727012579)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Scientfic, Inc.
Version or Model: HB936-294
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HB936-294
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727012579
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: Bilirubin, Direct Reagent Set for the quantitative determination of direct bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 12 x 19ml, 6 x 11ml

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?
53236	Conjugated (direct) bilirubin 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 quantitative measurement of conjugated (direct) bilirubin in a clinical specimen.	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: 26c08b60-6bbf-4a16-ad40-a7d3ed070032
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016