POINTE SCIENTIFIC CRP Standard Set (2.5, 10, 20, 80, 160 mg/L)

Basic Information

• Brand Name: POINTE SCIENTIFIC CRP Standard Set (2.5, 10, 20, 80, 160 mg/L)
• Primary DI: 00811727011053
• Version / Model: C7568-STD
• Catalog Number: C7568-STD
• 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: e4917e25-a4e2-46da-8fd2-4e89ac1e9de3

Device Description

The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set is intended to be used for the calibration of the manufacturer’s CRP (High Sensitivity) Wide Range immunoturbidimetric assay. For in vitro diagnostic use only.

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
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	866.5270	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41838	C-reactive protein (CRP) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811727011053	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K030545	000