Identity
- Trade Name
- IMMY FDA UDI
- Generic Name
- Cryptococcus neoformans antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Cryptococcus Antigen EIA FDA UDI
- Model / Reference
- CRY101 FDA UDI
- Description
- Cryptococcus Antigen EIA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816387020759 FDA UDI
- FDA Product Code
- MDU FDA UDI
- GMDN Term
- Cryptococcus neoformans antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3165 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
No
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: Cryptococcus neoformans antigen IVD, kit, enzyme immunoassay (EIA)
Immy by Immuno-Mycologics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cryptococcus neoformans antigen IVD, kit, enzyme immunoassay (EIA).
- PREMIER Cryptococcal Antigen — 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
- Immuno-Mycologics, Inc.
Sources (1)
- FDA UDI 194d0373-0a70-4dae-ab4d-73408f62d15d 34 fields · synced Jun 6, 2026