Determination of thrombin time in human plasma
Test Thrombin Reagent - 10873894
Device Description
A collection of reagents and other associated materials intended to be used for the quantitative measurement of the thrombin time (TT) of a clinical specimen using a clotting method.
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: GJA
Device Name: Test, Thrombin Time
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: 864.7875
Third Party Flag: Y
Medical Specialty: HE
Device Identifiers
Device Id: 00630414639635
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