Identity
- Trade Name
- ImmunoCard Mycoplasma FDA UDI
- Generic Name
- Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- The ImmunoCard Mycoplasma enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgM to Mycoplasma pneumoniae in human serum. Test results are intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection. FDA UDI
- Model / Reference
- 709030 FDA UDI
- Description
- The ImmunoCard Mycoplasma enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgM to Mycoplasma pneumoniae in human serum. Test results are intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection. FDA UDI
Identifiers
- Catalog Number
- 709030 FDA UDI
- Primary DI / UDI-DI
- 00840733101762 FDA UDI
- 510(k) Number
- K934550 FDA UDI
- FDA Product Code
- LJZ FDA UDI
- GMDN Term
- Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3375 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: Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical
ImmunoCard Mycoplasma by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI fcc81883-81dd-4a27-8235-e6800af3ea3a 37 fields · synced May 31, 2026