B2
IMMULITE® Systems BMG CONTROL Beta-2 Microglobulin - 10385587
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of beta-2-microglobulin in a clinical specimen.
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: JZG
Device Name: System, Test, Beta-2-Microglobulin Immunological
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: IM
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: 866.5630
Third Party Flag: N
Medical Specialty: IM
Device IdentifiersDevice Id: 00630414952956
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