For use in platelet aggregometry studies
Dade® Cluster® Platelet Aggregation Reagents - 10445725
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents and a nephelometry/turbidimetry method. Platelet aggregation agents used may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.
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: JOZ
Device Name: System, Automated Platelet Aggregation
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: 864.5700
Third Party Flag: Y
Medical Specialty: HE
Device IdentifiersDevice Id: 00842768003998
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