FDA.reportPublic FDA data

IMMUNODOT™ RICKETTSIA CONORII

Primary DI
00613745000015
Brand
IMMUNODOT™ RICKETTSIA CONORII
Company
GenBio
Model
800-4010
Catalog number
4010
Device description
The GenBio ImmunoDOT Rickettsia conorii (Mediterranean Spotted Fever) test is a semi-quantitative enzyme immunoassay for the detection of total IgG and IgM antibodies to Rickettsia conorii for the serological confirmation from serum, plasma or heparinized whole blood. This test is intended to be performed by trained medical technologists 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
00613745000015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745000015006137450000156137450000150613745000015

GMDN Terms#

Term, Definition table
TermDefinition
Rickettsia conorii 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 conorii in a clinical specimen using an immunoblot method. The assay is designed to detect infection with Rickettsia conorii, the rickettsial bacteria from the Spotted Fever Group.

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
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
00613745002316NGSgo Library Full Kit for Illumina IndX Plate I23421562025-12-26
00613745002323NGS-TurboAmp Multiplex 11 loci for ONT (12)93022102025-12-26
00613745002330NGSgo-MX11-373718642025-12-26
00613745002347NGS-TurboPrep Library preparation for ONT(12)93022202025-12-26
00613745002354NGSgo ProntoAmp HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)93036132025-12-26
00613745002361NGSgo ProntoPrep HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)93036232025-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613745000022IMMUNODOT™ Rickettsia TyphiGenBioLSQ2025-08-31
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