IgG FITC Conjugate w/ Evans Blue
IMMCO DIAGNOSTICS - 2099
Device Description
One or multiple immunoglobulins sourced from an animal (e.g., goat, sheep, mouse, rabbit) intended to be used in combination with other IVDs for the qualitative and/or quantitative detection of antihuman immunoglobulin G (IgG) antibodies. The immunoglobulin molecules are conjugated or bound by additional substances (e.g., fluorescent markers, peroxidase enzymes) for the detection of immune complexes in clinical specimens.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
- 5 ml
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MVM
Device Name: Autoantibodies, Endomysial(Tissue Transglutaminase)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 866.5660
Third Party Flag: Y
Medical Specialty: IM
Device IdentifiersDevice Id: 00845714002175
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