NGSgo-IndX Illumina Adapter & Indices plate I (96)

GUDID 00613745003443

Genbio

HLA class I & II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
Primary Device ID00613745003443
NIH Device Record Key6fab6225-c8ab-4e96-93d9-fcaaeabc185d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNGSgo-IndX Illumina Adapter & Indices plate I (96)
Version Model Number2342153
Company DUNS940425333
Company NameGenbio
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8585929300
Emailorders@genbio.com
Phone8585929300
Emailorders@genbio.com
Phone8585929300
Emailorders@genbio.com
Phone8585929300
Emailorders@genbio.com
Phone8585929300
Emailorders@genbio.com
Phone8585929300
Emailorders@genbio.com
Phone8585929300
Emailorders@genbio.com
Phone8585929300
Emailorders@genbio.com
Phone8585929300
Emailorders@genbio.com
Phone8585929300
Emailorders@genbio.com
Phone8585929300
Emailorders@genbio.com
Phone8585929300
Emailorders@genbio.com
Phone8585929300
Emailorders@genbio.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100613745003443 [Primary]

FDA Product Code

MZITest, Qualitative, For Hla, Non-Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-05
Device Publish Date2025-12-27

Devices Manufactured by Genbio

00613745001630 - NGSgo Library Full Kit for Illumina IndX Plate III2026-01-05
00613745002293 - NGSgo Library Full Kit for Illumina IndX Plate IV2026-01-05
00613745002309 - NGSgo-AmpX v2 HLA GeneSuite2026-01-05
00613745002316 - NGSgo Library Full Kit for Illumina IndX Plate I2026-01-05
00613745002323 - NGS-TurboAmp Multiplex 11 loci for ONT (12)2026-01-05
00613745002330 - NGSgo-MX11-32026-01-05
00613745002347 - NGS-TurboPrep Library preparation for ONT(12)2026-01-05
00613745002354 - NGSgo ProntoAmp HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)2026-01-05

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