FDA.reportPublic FDA data

NGSengine-Turbo Standard Entry (1 year)

Primary DI
00613745003825
Brand
NGSengine-Turbo Standard Entry (1 year)
Company
Genbio
Model
4109983
Published
2025-12-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00613745003825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745003825006137450038256137450038250613745003825

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
DM exempt
false
Premarket exempt
true
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
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
00613745002378NGSgo Library Full Kit for Illumina IndX plate II23422562025-12-26
00613745002446GenDx-LongMix50076522025-12-27
00613745002453Nuclease-Free Water3000000G-8344342-442025-12-27
00613745002491NGSgo-IndX Plate III 20023532025-12-27
00613745002576NGSgo-IndX Plate II20022532025-12-27
00613745002583NGSgo-IndX Plate IV20024532025-12-27
00613745002606NGSgo-AmpX v2 HLA-B7070262.12025-12-26
00613745002705 NGSgo-IndX Plate I (Indices Illumina)20021532025-12-27
00613745002859AlleleSEQR® HLA-A PCR/Sequencing kit (25)07K38-01G-8344342-442025-12-26
00613745002866AlleleSEQR® HLA-B PCR/Sequencing kit (25) 07K39-012025-12-26
00613745002873AlleleSEQR® HLA-C PCR/Sequencing kit (25) 07K40-032025-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00613745002330NGSgo-MX11-3GenbioMZI2025-12-26
00613745002347NGS-TurboPrep Library preparation for ONT(12)GenbioMZI2025-12-26
00613745002354NGSgo ProntoAmp HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)GenbioMZI2025-12-26
00613745002361NGSgo ProntoPrep HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)GenbioMZI2025-12-26
00613745002378NGSgo Library Full Kit for Illumina IndX plate IIGenbioMZI2025-12-26
00613745002606NGSgo-AmpX v2 HLA-BGenbioMZI2025-12-26
00613745002859AlleleSEQR® HLA-A PCR/Sequencing kit (25)GenbioMZI2025-12-26
00613745002866AlleleSEQR® HLA-B PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002873AlleleSEQR® HLA-C PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002880AlleleSEQR® HLA-DRB1 PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002897AlleleSEQR® HLA-DQB1 PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002903AlleleSEQR® HLA-DPB1 PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002910KMRengine Chimerism monitoring software One year extension GenbioMZI2025-12-26