FDA.reportPublic FDA data

ImmunoFLOW Mycoplasma IgM Positive Control

Primary DI
00613745000091
Brand
ImmunoFLOW Mycoplasma IgM Positive Control
Company
GenBio
Model
800-3925
Catalog number
3925
Device description
Mycoplasma IgM Control contains specific IgM type antibodies to Mycoplasma pneumoniae complement–fixing antigen and is used in conjunction with the appropriate ImmunoFLOW Assay Test System.
Published
2026-04-19
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613745000091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745000091006137450000916137450000910613745000091

GMDN Terms#

Term, Definition table
TermDefinition
Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Mycoplasma pneumoniae bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
858-592-9300orders@genbio.com

Regulatory Flags#

DUNS number
940425333
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
00613745003948ONtrack Amp83544402026-06-08
00613745003955ONtrack Prep83544502026-06-08
00613745003962HISTO SPOT ® HLA AB Reagent KitB3728198728198RUO2026-06-08
00613745003979HISTO SPOT ® HLA AB ID CLASS II – AD1B3728196728196RUO2026-06-08
00613745003986HISTO SPOT ® HLA AB ID CLASS IIB3728101728101RUO2026-06-08
00613745003993HISTO SPOT ® HLA AB ID CLASS IB3728100728100RUO2026-06-08
00613745003931NGSgo-AmpX v3 HLA-DRB3/4/5 (96)73337622026-05-15
00613745003870NGSgo®-AmpX v2 Enhancer707000112026-05-06
00613745003887NGSgo®-LibrX End Prep Enzyme200200512026-05-06
00613745003894NGSgo®-LibrX End Prep Buffer200200522026-05-06
00613745003900NGSgo®-LibrX Ligase Mix200200532026-05-06
00613745003917NGSgo®-LibrX Ligation Enhancer200200542026-05-06
00613745003924GenDx-LongMix500765212026-05-06
00613745002859AlleleSEQR® HLA-A PCR/Sequencing kit (25)07K38-012025-12-26
00613745000145ImmunoFLOW Negative Control Mycoplasma IgM800-392139212026-04-19
00613745003863NGSgo®-AmpX v270700012026-03-30
00613745001630NGSgo Library Full Kit for Illumina IndX Plate III23423562025-12-26
00613745002293NGSgo Library Full Kit for Illumina IndX Plate IV23424562025-12-26
00613745002309 NGSgo-AmpX v2 HLA GeneSuite73716622025-12-26
00613745002316NGSgo Library Full Kit for Illumina IndX Plate I23421562025-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840733101762ImmunoCard MycoplasmaMERIDIAN BIOSCIENCE, INC.LJZ2020-08-11
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