FDA.reportPublic FDA data

ImmunoFA Toxoplasma IgM

Primary DI
00613745013008
Brand
ImmunoFA Toxoplasma IgM
Company
GenBio
Model
800-1300
Catalog number
1300
Device description
The ImmunoFA Toxo IgM Test is an immunofluorescence test for the presumptive detection and titration of IgM antibodies to Toxoplasma gondii in human serum and is presumptive for the diagnosis of acute, recent, or reactivated T. gondii infection. It is intended that the ImmunoFA Toxo IgG Test be performed in conjunction with this assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GLZAntigens, If, Toxoplasma Gondii

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GLZAntigens, If, Toxoplasma GondiiMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K803134000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K803134000TOXOPLASMA GONDII SEROLOGICAL REAGENTSMicrobiological Research Corp.1981-01-29GLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613745013008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745013008006137450130086137450130080613745013008

GMDN Terms#

Term, Definition table
TermDefinition
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen, using a fluorescent immunoassay method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
858-592-9300support@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
00613745000091ImmunoFLOW Mycoplasma IgM Positive Control800-392539252026-04-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G5229020101Toxo IgG IFA 120 TestHemagen Diagnostics, Inc.GLZ2023-10-05
G5229020201Toxo IgG IFA 204 TestHemagen Diagnostics, Inc.GLZ2023-10-05
G5229020211Toxo IgG IFA Slide Only KitHemagen Diagnostics, Inc.GLZ2023-10-05
00650551147404sEEG DEPTHALONPMT CORPORATIONGLZ2020-05-07
00613745010052ImmunoFA 10x PBSGenBioGLZ2016-09-24
00613745010069ImmunoFA 10x PBSGenBioGLZ2016-09-24
00613745012001ImmunoFA Toxoplasma IgGGenBioGLZ2016-09-24
00613745012018ImmunoFA Toxoplasma SlidesGenBioGLZ2016-09-24
00613745012025ImmunoFA Toxoplasma IgG ConjugateGenBioGLZ2016-09-24
00613745012032ImmunoFA Toxoplasma IgG Negative ControlGenBioGLZ2016-09-24
00613745012049ImmunoFA Toxoplasma IgG Low ControlGenBioGLZ2016-09-24
00613745012056ImmunoFA Toxoplasma IgG High ControlGenBioGLZ2016-09-24
00613745012070ImmunoFA Toxoplasma SlidesGenBioGLZ2016-09-24
00613745013091ImmunoFA Toxoplasma IgM ConjugateGenBioGLZ2016-09-24
00613745013411ImmunoFA Toxoplasma IgM Positive ControlGenBioGLZ2016-09-24