K-ASSAY® ASO (WHO) Calibrator

Basic Information

• Brand Name: K-ASSAY® ASO (WHO) Calibrator
• Primary DI: 00816426020627
• Version / Model: KAI-079C
• Catalog Number: KAI-079C
• Company Name: KAMIYA BIOMEDICAL COMPANY, LLC
• Labeler DUNS: 197934250
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d32f7e96-9b1a-4d7d-9cbf-3f6a3f2036fd

Device Description

For the calibration of the K-ASSAY® ASO (WHO) assay.

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: Yes
• 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
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	866.3720	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51744	Beta-haemolytic Group A Streptococcus streptolysin O antibody 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 antibodies to streptolysin O enzyme produced by Group A beta-haemolytic Streptococcus bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816426020627	GS1

Customer Contacts

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

Storage Conditions

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