FDA.reportPublic FDA data

ImmunoCard Mycoplasma

Primary DI
00840733101762
Brand
ImmunoCard Mycoplasma
Company
MERIDIAN BIOSCIENCE, INC.
Model
709030
Catalog number
709030
Device description
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.
Published
2020-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934550000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934550000IMMUNOCARD MYCOPLASMAMeridian Diagnostics, Inc.1994-09-20LJZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101762008407331017628407331017620840733101762

GMDN Terms#

Term, Definition table
TermDefinition
Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative detection of immunoglobulin M (IgM) antibodies to Mycoplasma pneumoniae bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses, and is also available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
513-271-3700info@meridianbioscience.com
800-343-3858MBI-TechService@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840733101595StatID PRO COVID/Flu A&B Swabs7831107831102026-05-14
00840733101557statID Pro COVID-19/Flu External Controls7830102026-04-10
00840733101564statID Pro COVID-19/Flu A&B7830252026-04-10
00840733101717PREMIER CAMPY6180966180962020-09-01
00840733101397Fungal Immunodiffusion Plates - 4 Series1010091010092019-11-21
00840733101403Fungal Immunodiffusion Plates - 1 Series1010121010122019-11-21
00840733101014ANA Screen ELISA Test Kit488426148842612016-09-23
00840733102585Hemo-De8013008013002020-12-09
00840733102660Modified Hemo-De8016008016002020-09-21
00840733102318Revogene6102106102102020-07-15
00840733102547EcoStain8014008014002020-12-09
00840733102394SpinCon9722009722002020-10-26
00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613745000091ImmunoFLOW Mycoplasma IgM Positive ControlGenBioLJZ2026-04-19
00613745000145ImmunoFLOW Negative Control Mycoplasma IgMGenBioLJZ2026-04-19
00613745000060IMMUNOFLOW™ Mycoplasma pneumoniae IgM TestGenBioLJZ2025-08-31
00613745031200ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TESTGenBioLJZ2025-08-29
00613745031309ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TESTGenBioLJZ2025-08-29
ENTIMYCG03500NovaLisa Mycoplasma pneumoniae IgG Gold Standard Diagnostics Frankfurt GmbHLJZ2024-08-26
04048474045598Mycoplasma hominis IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJZ2023-08-31
04048474046236Ureaplasma urealyticum IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJZ2023-08-31
04048474034998Mycoplasma pneumoniae IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJZ2023-08-29
00840239046239Ureaplasma urealyticum IgG ELISADRG International IncLJZ2023-08-25
00840239034991Mycoplasma pneumoniae IgG ELISADRG International IncLJZ2023-08-24
00894175000749AccuDiag ™Diagnostic Automation, Inc.LJZ2023-06-14
00404847434996Mycoplasma pneumoniae IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJZ2021-06-07
00404847445596Mycoplasma hominis IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJZ2021-06-07
00404847446234Ureaplasma urealyticum IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJZ2021-06-07
05391516743945Trinity BiotechCLARK LABORATORIES, INC.LJZ2019-11-06
04049016027645Anti-Mycoplasma pneumoniae ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGLJZ2016-09-24
04049016027652Anti-Mycoplasma pneumoniae ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJZ2016-09-24
04049016027669Anti-Mycoplasma pneumoniae ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGLJZ2016-09-24
05391516743358Trinity BiotechCLARK LABORATORIES, INC.LJZ2016-09-21
00817273020419DiamedixDIAMEDIX CORPORATIONLJZ2016-09-20