The PREMIER Coccidioides enzyme immunoassay (EIA) is for the qualitative detection of IgM and IgG antibodies directed against the TP and CF antigens of Coccidioides immitis in serum and cerebrospinal fluid (CSF).
PREMIER Coccidioides - 603096
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the fungus Coccidioides immitis in a clinical specimen, using a precipitation/immunodiffusion 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: MIY
Device Name: Enzyme Linked Immunosorbent Assay, Coccidioides Immitis
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: 866.3135
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00840733101236
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