PF4 IgG is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum.
PF4 IgG - HAT13G
Device Description
A collection of reagents and other associated materials intended to be used for the quantitative measurement of platelet factor 4 in a clinical specimen using an enzyme immunoassay (EIA) 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: LCO
Device Name: Platelet Factor 4 Radioimmunoassay
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: 864.7695
Third Party Flag: Y
Medical Specialty: HE
Device IdentifiersDevice Id: 10888234500049
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