CONTROL 306
N/A - 306-03POR
Device Description
An electronic device that is used to measure, indicate, and/or record the length of time taken for plasma or a whole blood sample to form a clot following the initiation of a reaction, typically as part of in vitro coagulation studies.
Environmental Conditions
- Temperature Limit 2°C-10°C
- Lyophilized heparin assay controls must be refrigerated (2°C to 10°C [35.6°F to 50°F]) until use.
- Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C [35.6°F to 77°F])
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JOX
Device Name: Analyzer, Heparin, Automated
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: 864.5680
Third Party Flag: Y
Medical Specialty: HE
Device IdentifiersDevice Id: 00763000014773
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: 20763000014777
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