FDA.reportPublic FDA data

IMMUNODOT™ COXIELLA BURNETII (Q FEVER)

Primary DI
00613745000039
Brand
IMMUNODOT™ COXIELLA BURNETII (Q FEVER)
Company
GenBio
Model
800-4050
Catalog number
4050
Device description
The ImmunoDOT test is an enzyme immunoassay for the qualitative detection of antibodies to Coxiella burnetii in serum specimens and is used as an aid in the diagnosis of C. burnetii (Q fever) infection. The test is used as an aid for diagnosis of C. burnetii (Q fever) infection in subjects suspected with consistent signs and symptoms to suspect the infection.
Published
2025-09-01
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
GPJAntiserum, Fluorescent, Q Fever

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GPJAntiserum, Fluorescent, Q FeverMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613745000039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745000039006137450000396137450000390613745000039

GMDN Terms#

Term, Definition table
TermDefinition
Coxiella burnetii total 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 total antibodies to Coxiella burnetii in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Coxiella burnetii, the rickettsial bacteria associated with Q fever.

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
20816101020342Q Fever IFA IgGDIASORIN MOLECULAR LLCGPJ2026-03-13
20816101020359Q Fever IFA IgMDIASORIN MOLECULAR LLCGPJ2026-03-13