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ELISA M. pneumoniae IgM Smart Kit Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
ELISA M. pneumoniae IgM Smart Kit 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
SM3Z17601M 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
SM3Z17601M FDA UDI
Primary DI / UDI-DI
00845533000949 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

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, enzyme immunoassay (EIA)

ELISA M. pneumoniae IgM Smart Kit 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).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA UDI 89c6612b-c7b6-47bb-b8b6-c79806f4c7b4 35 fields · synced May 30, 2026