AccessGUDID - DEVICE: NGSgo®-AmpX v2 HLA-DRB1 (96) (00613745003641)

GUDID

Device Identifier (DI) Information

Brand Name: NGSgo®-AmpX v2 HLA-DRB1 (96)
Version or Model: 7370662
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GenBio

Primary DI Number: 00613745003641
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 940425333 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56366	HLA class 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 II antigens in a clinical specimen, using a nucleic acid technique (NAT). It may be used to detect specific HLA gene alleles associated with an inborn/inherited genetic disorder or a predisposition to develop an autoimmune disease (e.g., type 1 diabetes mellitus, Coeliac disease, narcolepsy, Crohn’s disease, inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis). It may also be used for selecting treatment options for immunotherapy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZI	Test, Qualitative, For Hla, Non-Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 24a6a963-ba55-41f9-add1-ca5001ac4042
Public Version Date: April 20, 2026
Public Version Number: 3
DI Record Publish Date: December 26, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8585929300
Email: orders@genbio.com

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