ImmunoCard Mycoplasma 709030

GUDID 00840733101762

The ImmunoCard Mycoplasma enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgM to Mycoplasma pneumoniae in human serum. Test results are intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.

MERIDIAN BIOSCIENCE, INC.

Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical
Primary Device ID00840733101762
NIH Device Record Keyfcc81883-81dd-4a27-8235-e6800af3ea3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunoCard Mycoplasma
Version Model Number709030
Catalog Number709030
Company DUNS092815364
Company NameMERIDIAN BIOSCIENCE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-19
Device Publish Date2020-08-11

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