FDA.reportPublic FDA data

SeroMP IgA

Primary DI
07290013348074
Brand
SeroMP IgA
Company
SAVYON DIAGNOSTICS LTD
Model
A263-01
Catalog number
A263-01
Device description
Semi-quantitative enzyme-linked immunosorbent assay (ELISA) kit for the detection of specific IgA antibodies to Mycoplasma pneumoniae in human serum. For professional use only.
Published
2026-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K882596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K882596000MP TESTDiatech Diagnostica , Ltd.1989-06-21LJZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290013348074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290013348074072900133480747290013348074

GMDN Terms#

Term, Definition table
TermDefinition
Mycoplasma pneumoniae immunoglobulin A (IgA) 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 A (IgA) antibodies to Mycoplasma pneumoniae bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
533708202
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290006418326CHROMOSTREAKBD-915BD-9152026-05-27
07290006418111DIASLIDE URINE CULTURING DEVICEDS-1052026-05-04
07290013348531URISCREEN 101-012026-04-29
17290006558937Feminine Screening KitF-1-VO-CVS022026-02-22
07290006558930Feminine Screening KitF-1-VO-CVS022026-02-22
07290001913147SeroELISA Chlamydia IgGA111-01A111-012025-05-29
07290001913161SeroELISA Chlamydia IgAA113-012025-05-29
07290013348302Conjugate IgAFA233-12MFA233-12M2023-06-29
07290013348470Conjugate IgMFA232-12MFA232-12M2023-06-29
07290016332193Serum Diluent IgMFB262-03MFB262-03M2023-06-29
07290016332636Bordetella Pertussis IgGA2231-01MA2231-01M2023-06-16
07290013348487Bordetella immunology reagents IgA2233-012233-012023-06-29
07290013348494Bordetella immunology reagents IgM2232-012232-012023-06-29

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
00817273020419DiamedixDIAMEDIX CORPORATIONLJZ2016-09-20