FDA.reportPublic FDA data

KMRengine Chimerism monitoring software One year extension

Primary DI
00613745002910
Brand
KMRengine Chimerism monitoring software One year extension
Company
GenBio
Model
4109751
Published
2025-12-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00613745002910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745002910006137450029106137450029100613745002910

GMDN Terms#

Term, Definition table
TermDefinition
Human genomic analysis interpretive software IVDAn in vitro diagnostic interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic results obtained through molecular genetic testing (e.g., whole genome, targeted genome, or exome analyses). It provides predictive and/or diagnostic information (e.g., gene-drug associations, congenital and/or acquired aneuploidy status, genotype-phenotype relationships) used by a professional in the assessment of patient adverse health condition risk, disease prevention, and/or health management, or for lifestyle guidance as pertains to a patient genomic profile.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8585929300orders@genbio.com

Regulatory Flags#

DUNS number
940425333
Device count
1
Premarket exempt
true
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
00613745003948ONtrack AmpGenBioMZI2026-06-08
00613745003955ONtrack PrepGenBioMZI2026-06-08
00613745003962HISTO SPOT ® HLA AB Reagent KitGenBioMZI2026-06-08
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