FDA.reportPublic FDA data

HISTO SPOT ® HLA AB Reagent Kit

Primary DI
00613745003962
Brand
HISTO SPOT ® HLA AB Reagent Kit
Company
GenBio
Model
B3728198
Catalog number
728198RUO
Published
2026-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZITest, Qualitative, For Hla, Non-Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZITest, Qualitative, For Hla, Non-DiagnosticUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613745003962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745003962006137450039626137450039620613745003962

GMDN Terms#

Term, Definition table
TermDefinition
HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple HLA class I antigens in a clinical specimen, using a nucleic acid technique (NAT).

Contacts#

Phone, Email table
PhoneEmail
8585929300orders@genbio.com

Regulatory Flags#

DUNS number
940425333
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613745003948ONtrack Amp83544402026-06-08
00613745003955ONtrack Prep83544502026-06-08
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
00613745002316NGSgo Library Full Kit for Illumina IndX Plate I23421562025-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613745003948ONtrack AmpGenBioMZI2026-06-08
00613745003955ONtrack PrepGenBioMZI2026-06-08
00613745003979HISTO SPOT ® HLA AB ID CLASS II – AD1GenBioMZI2026-06-08
00613745003986HISTO SPOT ® HLA AB ID CLASS IIGenBioMZI2026-06-08
00613745003993HISTO SPOT ® HLA AB ID CLASS IGenBioMZI2026-06-08
00613745003931NGSgo-AmpX v3 HLA-DRB3/4/5 (96)GenBioMZI2026-05-15
00613745003870NGSgo®-AmpX v2 EnhancerGenBioMZI2026-05-06
00613745003887NGSgo®-LibrX End Prep EnzymeGenBioMZI2026-05-06
00613745003894NGSgo®-LibrX End Prep BufferGenBioMZI2026-05-06
00613745003900NGSgo®-LibrX Ligase MixGenBioMZI2026-05-06
00613745003917NGSgo®-LibrX Ligation EnhancerGenBioMZI2026-05-06
00613745003924GenDx-LongMixGenBioMZI2026-05-06
00613745003863NGSgo®-AmpX v2GenBioMZI2026-03-30
00613745002446GenDx-LongMixGenBioMZI2025-12-27
00613745002453Nuclease-Free WaterGenBioMZI2025-12-27
00613745002491NGSgo-IndX Plate IIIGenBioMZI2025-12-27
00613745002576NGSgo-IndX Plate IIGenBioMZI2025-12-27
00613745002705 NGSgo-IndX Plate I (Indices Illumina)GenBioMZI2025-12-27
00613745003443NGSgo-IndX Illumina Adapter & Indices plate I (96) GenBioMZI2025-12-27
00613745003450NGSgo-IndX Illumina Adapter & Indices plate II (96) GenBioMZI2025-12-27
00613745003474NGSgo-IndX Illumina Adapter & Indices plate IV (96) GenBioMZI2025-12-27
00613745003481GenDx-AMPure XP - AMPure beads and elution buffer (5 ml) GenBioMZI2025-12-27
00613745003689NGS-Turbo® demo workflow reagentsGenBioMZI2025-12-27
00613745003702NGSgo® Pronto demo Workflow reagentsGenBioMZI2025-12-27
00613745003719NGSgo® Pronto demo Wash reagentsGenBioMZI2025-12-27
00613745001630NGSgo Library Full Kit for Illumina IndX Plate IIIGenBioMZI2025-12-26
00613745002293NGSgo Library Full Kit for Illumina IndX Plate IVGenBioMZI2025-12-26
00613745002309 NGSgo-AmpX v2 HLA GeneSuiteGenBioMZI2025-12-26
00613745002316NGSgo Library Full Kit for Illumina IndX Plate IGenBioMZI2025-12-26
00613745002323NGS-TurboAmp Multiplex 11 loci for ONT (12)GenBioMZI2025-12-26