Primary Device ID | 03610230004524 |
NIH Device Record Key | 23aa9667-12ef-42fa-84ec-81bd20da47f4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MINIPACK AD60 (x4) |
Version Model Number | 1210606051 |
Company DUNS | 273647420 |
Company Name | HORIBA ABX SAS |
Device Count | 4 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03610230004524 [Primary] |
GS1 | 03610230008096 [Unit of Use] |
PPM | General Purpose Reagent |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2023-06-02 |
Device Publish Date | 2016-09-20 |
03610230005545 - ABX PENTRA CK CONTROL | 2024-07-18 |
03610230005392 - ABX PENTRA HBA1C WB | 2024-07-16 |
03610230005408 - ABX PENTRA HBA1C WB CAL | 2024-07-16 |
03610230005415 - ABX PENTRA HBA1C WB CONTROL | 2024-07-16 |
03610230005460 - ABX PENTRA HBA1C WB HEMOLYSIS REAGENT | 2024-07-16 |
03610230008157 - NUCEDIFF (1L) | 2024-06-07 |
03610230008508 - Yumizen SPS | 2024-06-07 |
03610230008928 - Yumizen T6000 | 2024-06-07 Right module SPS only |