FDA.reportPublic FDA data

IMMUNODOT™ Rickettsia Typhi

Primary DI
00613745000022
Brand
IMMUNODOT™ Rickettsia Typhi
Company
GenBio
Model
800-4020
Catalog number
4020
Device description
The GenBio R. typhi (murine typhus) test is a semi-quantitative enzyme immunoassay for the detection of IgG and IgM antibodies to Rickettsia typhi as an aid in the presumptive diagnosis of murine typhus from serum, heparinized plasma or heparinized whole blood. This test is to be performed by trained medical personnel only.
Published
2025-08-31
Public version status
Update
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
LSQReagent, Rickettsia Serological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSQReagent, Rickettsia SerologicalMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613745000022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745000022006137450000226137450000220613745000022

GMDN Terms#

Term, Definition table
TermDefinition
Rickettsia typhi total antibody IVD, kit, immunoblotA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Rickettsia typhi in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Rickettsia typhi, the rickettsial bacteria associated with endemic typhus.

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
858-592-9300orders@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
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
00613745000015IMMUNODOT™ RICKETTSIA CONORIIGenBioLSQ2025-08-31
04048474052978Rickettsia IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSQ2023-09-01
00840239052971Rickettsia IgG ELISADRG International IncLSQ2021-06-07
B266RTG96K0Rickettsia typhi IgG ELISA KitFULLER LABORATORIESLSQ2019-10-31
00813545026066O. Tsutsugamushi(Scrub Typhus) 12 well; 10 pkSCIMEDX CORPORATIONLSQ2016-09-21
00813545026073C. burnetii 12 Well 10 pk SCIMEDX CORPORATIONLSQ2016-09-21
00813545026080R. Conorii 12 well; 10 pkSCIMEDX CORPORATIONLSQ2016-09-21
00813545026103R. Prowazekii 12 well; 10 pk SCIMEDX CORPORATIONLSQ2016-09-21
00813545026110R. Rickettsii 12 well; 10 pk SCIMEDX CORPORATIONLSQ2016-09-21
00813545026141Rickettsia typhi 12 well;10 pk SCIMEDX CORPORATIONLSQ2016-09-21
00813545026295Rickettsia rickettsii (RMSF) Latex 30 Test KiSCIMEDX CORPORATIONLSQ2016-09-21
00813545025649Ehrlichia chaffeensis 12wl; 10 pkSCIMEDX CORPORATIONLSQ2016-09-20
10888234001003REStIMMUCOR, INC.LSQ2016-04-19