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ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST

FDA UDI

Class I (US FDA UDI)

by Genbio

Identity

Trade Name
ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST FDA UDI
Generic Name
Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
ImmunoWELL Mycoplasma Pneumoniae Antibody (IgM) Test is a qualitative enzyme immunoassay (EIA) for the detection of specific IgM antibodies to M. pneumoniae in serum and is an aid in the diagnosis of M. pneumoniae infection. FDA UDI
Model / Reference
800-3130 FDA UDI
Description
ImmunoWELL Mycoplasma Pneumoniae Antibody (IgM) Test is a qualitative enzyme immunoassay (EIA) for the detection of specific IgM antibodies to M. pneumoniae in serum and is an aid in the diagnosis of M. pneumoniae infection. FDA UDI

Identifiers

Catalog Number
3130 FDA UDI
Primary DI / UDI-DI
00613745031309 FDA UDI
FDA Product Code
LJZ FDA UDI
GMDN Term
Mycoplasma pneumoniae immunoglobulin M (IgM) 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 M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST by Genbio — Class I — 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
Genbio

Sources (1)

  • FDA UDI ba0eaddc-d58e-48f9-a8a6-2fc24ce7ab0e 37 fields · synced May 30, 2026