NGSgo ProntoAmp HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)

GUDID 00613745002354

Genbio

HLA class I & II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00613745002354
• NIH Device Record Key: d193f09c-03ae-4e15-b999-33bb431d02e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NGSgo ProntoAmp HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)
• Version Model Number: 9303613
• Company DUNS: 940425333
• Company Name: Genbio
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8585929300
• Email: orders@genbio.com
• Phone: 8585929300
• Email: orders@genbio.com
• Phone: 8585929300
• Email: orders@genbio.com
• Phone: 8585929300
• Email: orders@genbio.com
• Phone: 8585929300
• Email: orders@genbio.com
• Phone: 8585929300
• Email: orders@genbio.com
• Phone: 8585929300
• Email: orders@genbio.com
• Phone: 8585929300
• Email: orders@genbio.com
• Phone: 8585929300
• Email: orders@genbio.com
• Phone: 8585929300
• Email: orders@genbio.com
• Phone: 8585929300
• Email: orders@genbio.com
• Phone: 8585929300
• Email: orders@genbio.com
• Phone: 8585929300
• Email: orders@genbio.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613745002354 [Primary]

FDA Product Code

• MZI: Test, Qualitative, For Hla, Non-Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-05
• Device Publish Date: 2025-12-26

Devices Manufactured by Genbio

• 00613745001630 - NGSgo Library Full Kit for Illumina IndX Plate III: 2026-01-05
• 00613745002293 - NGSgo Library Full Kit for Illumina IndX Plate IV: 2026-01-05
• 00613745002309 - NGSgo-AmpX v2 HLA GeneSuite: 2026-01-05
• 00613745002316 - NGSgo Library Full Kit for Illumina IndX Plate I: 2026-01-05
• 00613745002323 - NGS-TurboAmp Multiplex 11 loci for ONT (12): 2026-01-05
• 00613745002330 - NGSgo-MX11-3: 2026-01-05
• 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
• 00613745002354 - NGSgo ProntoAmp HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96): 2026-01-05