Calibrator Level 1

Basic Information

• Brand Name: Calibrator Level 1
• Primary DI: 00817439020321
• Version / Model: CA1100
• Catalog Number: CA1100
• Company Name: Medtest Dx, Inc.
• Labeler DUNS: 070371210
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-30
• Public Version: 4
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 1fabe77f-07de-48a3-bcb6-6f1372d33984

Device Description

For use as a Calibrator in clinical chemistry assays. Calibration Serum Level 1 is based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays on a wide range of automatic analyzers. Constituent concentrations are available at 1 level.

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
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47868	Multiple-type clinical chemistry analyte profile 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 multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817439020321	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K061056	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 30 Degrees Celsius