For use with i
i-STAT PTplus Control Level
2 - 06P17-18
Device Description
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR).
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GJS
Device Name: Test, Time, Prothrombin
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: 864.7750
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 10054749004857
Device Type: Unit of Use
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
Device Id: 00054749004850
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