FDA.reportPublic FDA data

ImmunoDOT Leptospira IgM

Primary DI
00613745000169
Brand
ImmunoDOT Leptospira IgM
Company
GenBio
Model
800-4032
Catalog number
4032
Device description
The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptospira biflexa (serovar patoc 1). This test is presumptive for the laboratory diagnosis of leptospirosis. The IgM ImmunoDOT Test may be used to evaluate a single specimen or paired specimens to detect seroconversion. The test is intended for use in serum, plasma, heparinized whole blood or finger stick capillary blood.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GRYAntigens, All, Leptospira Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GRYAntigens, All, Leptospira Spp.Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002024000PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXAPanbio, Inc.2000-11-22GRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613745000169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745000169006137450001696137450001690613745000169

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Leptospira species 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 one or multiple species of Leptospira bacteria in a clinical specimen, using an enzyme immunoassay (EIA) 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
ENTILEPG06600NovaLisa Leptospira IgGGold Standard Diagnostics Frankfurt GmbHGRY2024-08-26
ENTILEPG0660NovaLisa Leptospira IgGGold Standard Diagnostics Frankfurt GmbHGRY2024-08-26
00850049545211AccuDiag ™Diagnostic Automation, Inc.GRY2024-03-06
04048474042450Leptospira IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungGRY2023-08-31
00840239057518Leptospira IgG ELISA DRG International IncGRY2023-08-25
04048474057515Leptopspira IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGRY2019-06-10
00404847457513Leptopspira IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGRY2019-06-10
00840239042453Leptopspira IgG ELISADRG International IncGRY2019-06-05
00613745000046ImmunoDOT Leptospira IgMGenBioGRY2016-09-24
00613745000152ImmunoDOT Leptospira IgMGenBioGRY2016-09-24
00813545026318Leptospira IgG Antibody 96 Test SCIMEDX CORPORATIONGRY2016-09-21