LIFECODES B
LIFECODES® B-Screen® - BCSG
Device Description
A collection of reagents and other associated materials intended to be used in screening for one or multiple antibodies to HLA class II antigens in a clinical specimen, using solid phase antigens together with an enzyme (EIA) immunoassay 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: KSZ
Device Name: System, Test, Automated Blood Grouping And Antibody
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: 864.9175
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 10888234500063
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