FDA.reportPublic FDA data

NGSgo Library Full Kit for Illumina IndX Plate III

Primary DI
00613745001630
Brand
NGSgo Library Full Kit for Illumina IndX Plate III
Company
GenBio
Model
2342356
Published
2025-12-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00613745001630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745001630006137450016306137450016300613745001630

GMDN Terms#

Term, Definition table
TermDefinition
HLA class I & II 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 and II antigens in a clinical specimen, using a nucleic acid technique method (NAT).

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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