Identity
- Trade Name
- NovaLisa Mycoplasma pneumoniae IgG FDA UDI
- Generic Name
- Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Mycoplasma pneumoniae IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mycoplasma pneumoniae in human serum or plasma (citrate, heparin). FDA UDI
- Model / Reference
- MYCG0350 FDA UDI
- Description
- The Mycoplasma pneumoniae IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mycoplasma pneumoniae in human serum or plasma (citrate, heparin). FDA UDI
Identifiers
- Catalog Number
- MYCG0350 FDA UDI
- Primary DI / UDI-DI
- ENTIMYCG03500 FDA UDI
- FDA Product Code
- LJZ FDA UDI
- GMDN Term
- Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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 G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
NovaLisa Mycoplasma pneumoniae IgG by Gold Standard Diagnostics Frankfurt GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
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- Mycoplasma pneumoniae IgG ELISA — DRG International, Inc. · Class I
- ELISA M. pneumoniae Q IgG Test System — ZEUS SCIENTIFIC, INC.
- ELISA M. pneumoniae IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST — Genbio · Class I
- Anti-Mycoplasma pneumoniae ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · Class I
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
- Gold Standard Diagnostics Frankfurt GmbH
Sources (1)
- FDA UDI 121424cc-7340-459c-9657-b5a7e1b6a12e 36 fields · synced May 31, 2026