Identity
- Trade Name
- ELISA M. pneumoniae IgM Test System FDA UDI
- Generic Name
- Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Mycoplasma pneumoniae IgM Test System provides a means for the qualitative detection of IgM antibodies to Mycoplasma pneumoniae in human sera. When performed according to these instructions, the results of this test may aid in the diagnosis of M. pneumoniae infections in the adult population. This assay is for In Vitro diagnostic use only. FDA UDI
- Model / Reference
- 3Z17601M FDA UDI
- Description
- The ZEUS ELISA Mycoplasma pneumoniae IgM Test System provides a means for the qualitative detection of IgM antibodies to Mycoplasma pneumoniae in human sera. When performed according to these instructions, the results of this test may aid in the diagnosis of M. pneumoniae infections in the adult population. This assay is for In Vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- 3Z17601M FDA UDI
- Primary DI / UDI-DI
- 00845533000932 FDA UDI
- GMDN Term
- Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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, enzyme immunoassay (EIA)
ELISA M. pneumoniae IgM Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).
- IMMUNOFLOW™ Mycoplasma pneumoniae IgM Test — Genbio · Class I
- ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST — Genbio · Class I
- AccuDiag ™ — Diagnostic Automation, Inc. · Class I
- Trinity Biotech — CLARK LABORATORIES, INC. · Class I
- ELISA M. pneumoniae IgM Smart Kit Test System — ZEUS SCIENTIFIC, INC.
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI 58c723c1-8d42-4f62-9490-7d391ec86100 35 fields · synced May 30, 2026