Pointe Scientific, Inc.

Basic Information

• Brand Name: Pointe Scientific, Inc.
• Primary DI: 00811727014573
• Version / Model: H7575-57
• Catalog Number: H7575-57
• 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: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 935f27c7-a6a6-4986-ae2f-4841acd7dbf5

Device Description

Liquid Stable 2-Part Homocysteine Reagent, intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Size: 1 x 50 mL, 1 x 7 mL, 2 x 3 mL

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
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	862.1377	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53747	Homocysteine IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of homocysteine in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811727014573	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K083222	000

Storage Conditions

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