Asserachrom® ß-TG - 00950
Device Description
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.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JBX
Device Name: Aggregrometer, Platelet
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.6675
Third Party Flag: Y
Medical Specialty: HE
Device IdentifiersDevice Id: 03607450009507
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A