FDA.reportPublic FDA data

NGSgo-AmpX v2 HLA-B

Primary DI
00613745002606
Brand
NGSgo-AmpX v2 HLA-B
Company
GenBio
Model
7070262.1
Published
2025-12-26
Public version status
Update
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#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613745002606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745002606006137450026066137450026060613745002606

GMDN Terms#

Term, Definition table
TermDefinition
HLA class I & II antigen nucleic acid tissue typing IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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.

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
00613745004006NGSgo-Pronto FLX HLA-A93551142026-06-11
00613745004013NGSgo-ProntoFLX DQA1/DQB193555142026-06-11
00613745004020NGSgo-Pronto FLX HLA-B93552142026-06-11
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
00613745003863NGSgo®-AmpX v270700012026-03-30
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
00613745003931NGSgo-AmpX v3 HLA-DRB3/4/5 (96)73337622026-05-15
00613745001630NGSgo Library Full Kit for Illumina IndX Plate III23423562025-12-26
00613745002293NGSgo Library Full Kit for Illumina IndX Plate IV23424562025-12-26
00613745002309NGSgo-AmpX v2 HLA GeneSuite73716622025-12-26