Asserachrom® ß-TG

Basic Information

• Brand Name: Asserachrom® ß-TG
• Primary DI: 03607450009507
• Version / Model: 00950
• Company Name: DIAGNOSTICA STAGO
• Labeler DUNS: 262277122
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 4
• Public Version Date: 2021-05-03
• Public Version Status: Update
• Public Device Record Key: f7e23908-2b3f-44b5-80d1-f8695b5b8f12

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
JBX	AGGREGROMETER, PLATELET	Hematology	864.6675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62189	Beta-thromboglobulin IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative detection of beta-thromboglobulin in a clinical specimen, using an enzyme immunoassay (EIA) method. Beta-thromboglobulin is a marker of platelet activation associated with various conditions such as thromboembolism, myocardial infarction and renal disorders.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03607450009507	GS1

Premarket Submissions

Submission Number	Supplement Number
K862775	000

Storage Conditions

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