Model: 70700011
DI: 00613745003870
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0670794a-084e-4eee-86c0-7f4d64e54a71
Distribution Status:
In Commercial Distribution
DUNS Number:
940425333
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00613745003870
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 56403
Name: HLA class I & II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
Definition:
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).
FDA Product Codes
MZI
Test, Qualitative, For Hla, Non-Diagnostic