ABX Minocal 5300100300

GUDID 03610230009611

HORIBA ABX SAS

Full blood count IVD, calibrator
Primary Device ID03610230009611
NIH Device Record Keyfdeade35-99d5-4fd1-9378-1d19d7f444f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameABX Minocal
Version Model Number5300100300
Catalog Number5300100300
Company DUNS273647420
Company NameHORIBA ABX SAS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103610230009611 [Primary]

FDA Product Code

KSACalibrator For Red-Cell And White-Cell Counting

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-07
Device Publish Date2024-09-27

Devices Manufactured by HORIBA ABX SAS

03610230009444 - Yumizen H25002024-12-09
03610230009451 - Yumizen H25002024-12-09
03610230009611 - ABX Minocal2024-10-07
03610230009611 - ABX Minocal2024-10-07
03610230008584 - BFTROL2024-10-04 BF Hematology control
03610230009581 - ABX Minotrol 162024-10-03
03610230009598 - ABX Minotrol 162024-10-03
03610230009604 - ABX Minotrol 162024-10-03
03610230005545 - ABX PENTRA CK CONTROL2024-07-18

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