FDA.reportPublic FDA data

Diamedix

Primary DI
00817273020419
Brand
Diamedix
Company
DIAMEDIX CORPORATION
Model
720-850
Device description
"""720-850 Mycoplasma IgG Test Kit"""
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00817273020419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817273020419008172730204198172730204190817273020419

GMDN Terms#

Term, Definition table
TermDefinition
Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic tapeworms Echinococcus granulosus and/or Echinococcus multilocularis, in a clinical specimen.

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
305-324-2300customerservice@erbadiagnostic.com

Regulatory Flags#

DUNS number
151765328
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817273020167Diamedix720-3302016-09-20
00817273020181Diamedix720-3502016-09-20
00817273020044Diamedix300-371A2016-09-20
00817273020013Diamedix251-0352016-09-20
00817273020372Diamedix720-7002016-09-20
00817273020006Diamedix250-0302016-09-20
00817273020020Diamedix300-312A2016-09-20
00817273020037Diamedix300-331A2016-09-20
00817273020051Diamedix720-1302016-09-20
00817273020068Diamedix720-2302016-09-20
00817273020075Diamedix720-2402016-09-20
00817273020082Diamedix720-2502016-09-20
00817273020099Diamedix72-2602016-09-20
00817273020105Diamedix720-2702016-09-20
00817273020112Diamedix720-2802016-09-20
00817273020129Diamedix720-2902016-09-20
00817273020136Diamedix720-3002016-09-20
00817273020143Diamedix720-3102016-09-20
00817273020150Diamedix720-3202016-09-20
00817273020174Diamedix720-3402016-09-20

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
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