Pointe Calcium Reagent

Basic Information

• Brand Name: Pointe Calcium Reagent
• Primary DI: 00811727016065
• Version / Model: 16-HC902-480
• Catalog Number: 16-HC902-480
• Company Name: POINTE SCIENTIFIC, INC.
• Labeler DUNS: 045623154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-30
• Public Version: 1
• Public Version Date: 2021-02-08
• Public Version Status: New
• Public Device Record Key: fbf49a8a-2107-4268-bbe7-e0373bd9a8bd

Device Description

Pointe Calcium Reagent packaged for use on the Mindray BA800. 5 x 66ml R1, 5 x 30ml R2. For the quantitative determination of calcium in serum on Mindray BA-800M analyzers. For in vitro diagnostic use only. Rx 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
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	862.1145	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52875	Calcium (Ca2+) 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 calcium (Ca2+) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811727016065	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K822469	000

Storage Conditions

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