Protein 2 Calibration Verifier Set for the Roche Integra

Basic Information

• Brand Name: Protein 2 Calibration Verifier Set for the Roche Integra
• Primary DI: 00817238010677
• Version / Model: 98502
• Company Name: CLINIQA CORPORATION
• Labeler DUNS: 078742335
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-31
• Public Version: 1
• Public Version Date: 2020-02-10
• Public Version Status: New
• Public Device Record Key: 6b9be562-2e35-4f83-a571-5e05966bdc80

Device Description

Protein 2 Calibration Verifier Set for the Roche Integra

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53593	Multiple clinical chemistry protein IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817238010677	GS1

Premarket Submissions

Submission Number	Supplement Number
K023250	000