Pointe Scientfic, Inc.

Basic Information

• Brand Name: Pointe Scientfic, Inc.
• Primary DI: 00811727012579
• Version / Model: HB936-294
• Catalog Number: HB936-294
• Company Name: POINTE SCIENTIFIC, INC.
• Labeler DUNS: 045623154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 26c08b60-6bbf-4a16-ad40-a7d3ed070032

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	862.1110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811727012579	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K040391	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius