STA® - Unicalibrator

Basic Information

• Brand Name: STA® - Unicalibrator
• Primary DI: 13607450006756
• Version / Model: 00675
• Company Name: DIAGNOSTICA STAGO
• Labeler DUNS: 262277122
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 4
• Public Version Date: 2021-04-23
• Public Version Status: Update
• Public Device Record Key: bae28d89-361e-4253-932f-0c5364fe1e1c

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: Yes
• 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
GIZ	PLASMA, CONTROL, NORMAL	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55995	Multiple coagulation factor 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 determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	13607450006756	GS1
Unit of Use	03607450006759	GS1

Premarket Submissions

Submission Number	Supplement Number
K922021	000

Storage Conditions

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