MINIPACK AD60 (x4)

GUDID 03610230004524

HORIBA ABX SAS

Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD

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 Identifiers

Device Issuing Agency	Device ID
GS1	03610230004524 [Primary]
GS1	03610230008096 [Unit of Use]

FDA Product Code

PPM	General Purpose Reagent

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2023-06-02
Device Publish Date	2016-09-20

Devices Manufactured by HORIBA ABX SAS

03610230004890 - ABX PENTRA ALP CP	2023-07-06
03610230004913 - ABX PENTRA AMYLASE CP	2023-07-06
03610230004920 - ABX PENTRA AST CP	2023-07-06
03610230004937 - ABX PENTRA GGT CP	2023-07-06
03610230004944 - ABX PENTRA LIPASE CP	2023-07-06
03610230004975 - ABX PENTRA CHOLESTEROL CP	2023-07-06
03610230004982 - ABX PENTRA BILIRUBIN, DIRECT CP	2023-07-06
03610230004999 - ABX PENTRA HDL DIRECT CP	2023-07-06