The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative and
semiquantitative determination of IgG
Candida albicans IgG ELISA - EIA-3458
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 the yeast Candida albicans in a clinical specimen, using an enzyme immunoassay (EIA) method.
Environmental Conditions
No Data Available
Device Sizes
- Stop Solution
- Total Volume: 30 Milliliter
- Wash Solution
- Enzyme Conjugate
- Sample Diluent
- Total Volume: 14 Milliliter
- Total Volume: 20 Milliliter
- Substrate Solution
- Positive Control
- Negative Control
- Cut-off Control
- Total Volume: 2 Milliliter
- Total Volume: 100 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LSG
Device Name: Candida Species, Antibody Detection
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: MI
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: 866.3165
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00840239034588
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