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ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST
FDA UDIClass I (US FDA UDI)
by Genbio
Identity
- Trade Name
- ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST FDA UDI
- Generic Name
- Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoWELL Mycoplasma Pneumoniae Antibody (IgG) Test is a semi–quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The test may be used to evaluate paired sera for the presence of seroconversion and a significant increase in specific IgG and in the diagnosis of Mycoplasma pneumoniae infection in the adult population. FDA UDI
- Model / Reference
- 800-3120 FDA UDI
- Description
- ImmunoWELL Mycoplasma Pneumoniae Antibody (IgG) Test is a semi–quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The test may be used to evaluate paired sera for the presence of seroconversion and a significant increase in specific IgG and in the diagnosis of Mycoplasma pneumoniae infection in the adult population. FDA UDI
Identifiers
- Catalog Number
- 3120 FDA UDI
- Primary DI / UDI-DI
- 00613745031200 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
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 G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST by Genbio — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- Mycoplasma pneumoniae IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- ELISA M. pneumoniae IgG Test System — ZEUS SCIENTIFIC, INC.
- Trinity Biotech — CLARK LABORATORIES, INC. · Class I
- Mycoplasma pneumoniae IgG ELISA — DRG International, Inc. · Class I
- ELISA M. pneumoniae Q IgG Test System — ZEUS SCIENTIFIC, INC.
- NovaLisa Mycoplasma pneumoniae IgG — Gold Standard Diagnostics Frankfurt GmbH · Class I
- ELISA M. pneumoniae IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- 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
- Genbio
Sources (1)
- FDA UDI e2a80941-1921-404a-b3b1-8e54e450a065 37 fields · synced May 30, 2026