Primary Device ID | 03610230005026 |
NIH Device Record Key | 1f84fcfc-283a-487a-bb43-36970b600a6d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ABX PENTRA BILIRUBIN, TOTAL CP |
Version Model Number | 1220001639 |
Company DUNS | 273647420 |
Company Name | HORIBA ABX SAS |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 03610230005026 [Primary] |
CIG | Diazo Colorimetry, Bilirubin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2023-07-06 |
Device Publish Date | 2016-08-23 |
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 |
03610230008935 - Yumizen T6000 | 2024-06-07 Right module Inst only |