"720
Diamedix - 720-540
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Measles virus in a clinical specimen, using a complement fixation test (CFT).
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: LJB
Device Name: Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Device Class: 1
Physical State: IVD reagent kit
Definition: The qualitative detection of measles specific IgG antibodies in serum or plasma.
Submission Type ID: 4
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: antigens and antisera used for the detection of measles antibodies
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Not applicable in vitro use
Regulation Number: 866.3520
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00817273020303
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