Identity
- Trade Name
- PREMIER Coccidioides FDA UDI
- Generic Name
- Coccidioides immitis total antibody IVD, kit, precipitation/immunodiffusion FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- 603096 FDA UDI
- Description
- 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). FDA UDI
Identifiers
- Catalog Number
- 603096 FDA UDI
- Primary DI / UDI-DI
- 00840733101236 FDA UDI
- 510(k) Number
- K915493 FDA UDI
- FDA Product Code
- MIY FDA UDI
- GMDN Term
- Coccidioides immitis total antibody IVD, kit, precipitation/immunodiffusion FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3135 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coccidioides immitis total antibody IVD, kit, precipitation/immunodiffusion
PREMIER Coccidioides by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coccidioides immitis total antibody IVD, kit, precipitation/immunodiffusion.
- IMMY — Immuno-Mycologics, Inc. · Class II
- Coccidioides "TP" Antigen for Fungal Immunodiffusion — MERIDIAN BIOSCIENCE, INC. · Class II
- Coccidioides "F" Antigen for Fungal Immunodiffusion — MERIDIAN BIOSCIENCE, INC. · Class II
- Coccidioides "F" Antigen for Fungal Immunodiffusion — MERIDIAN BIOSCIENCE, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI 0a8f7890-c949-4855-80eb-7e4dd6835547 37 fields · synced May 30, 2026