Pointe Scientific, Inc.

Basic Information

• Brand Name: Pointe Scientific, Inc.
• Primary DI: 00811727014634
• Version / Model: HA902-2000
• Catalog Number: HA902-2000
• 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: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 2fe047af-57fd-4df2-b427-4473018e839e

Device Description

Albumin Reagent, for the quantitative determination of Albumin in serum. Size: 1 x 2L

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
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	862.1035	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59071	Albumin IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using a spectrophotometry method. It is typically used for the detection of small amounts of albumin in urine as an indicator of a kidney disease known as moderately increased albuminuria or microalbuminuria.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811727014634	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K822471	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius