LINEARITY KIT 313
HEPline® - 313-50
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
- The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
- Store tubes in the box until the time of use.
- If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
- 10.00
- 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: JPA
Device Name: System, Multipurpose For In Vitro Coagulation Studies
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: 864.5425
Third Party Flag: Y
Medical Specialty: HE
Device IdentifiersDevice Id: 00763000014902
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