← Back to manufacturers

Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

Horiba Abx

US

Last updated May 24, 2026

Part of Horiba Abx Sas

What Horiba Abx makes

Horiba Abx manufactures in vitro diagnostics (IVDs) for laboratory use, including haematological cell analysers like the ABX MINILYSE and ABX PENTRA series for full blood count testing, as well as clinical chemistry analysers such as the ABX MICROS ES60 CT for protein assays and blood gas/electrolyte measurements. The company also produces calibrators and controls for C-reactive protein (CRP), albumin, ferritin, cystatin C, immunoglobulins, and other analytes, including spectrophotometric total protein kits. Devices like the Yumizen C1200 series support immunochemistry and enzyme-linked assays for specific biomarkers.

The company’s products are regulated under FDA pathways, including 510(k) clearances and UDI compliance, with devices classified as Class I and Class II. These diagnostics are listed in the FDA’s regulatory databases and are intended for clinical laboratory settings in the United States. The manufacturer operates from its US headquarters.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
—
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
—

Catalogue (184)

Page 4 of 4
DeviceModel / ReferenceRegistriesClassStatus
Abx Pentra Alp Cp 1220001626
FDA UDI
Class IIActive
Yumizen C1200 U/CSF L1 Micro Alb Control 1300023948
FDA UDI
Class IActive
Yumizen C1200 Level 1 Protein Control 1300023944
FDA UDI
Class IActive
Abx Pentra Co2 Control 1220001650
FDA UDI
Class IActive
Yumizen C1200 Urea 1300023869
FDA UDI
Class IIActive
Yumizen C1200 Cholesterol 1300023838
FDA UDI
Class IActive
Abx Pentra Iron Cp 1220001637
FDA UDI
Class IActive
Yumizen C1200 Level 1 CRPhs Control 1300071247
FDA UDI
Class IActive
Yumizen C1200 TPU Cal 1300047913
FDA UDI
Class IIActive
Yumizen C1200 LDL Direct 1300023857
FDA UDI
Class IActive
Abx Pentra Df 120 1280100006, 1280100007, 1280100008, 1280100010
FDA UDI
Class IIActive
Abx Micros 60 Os 1280070105, 1280070106
FDA UDI
Class IIActive
Abx Pentra 60 1280120065, 1280120067
FDA UDI
Class IIActive
Abx Pentra Ggt Cp 1220001630
FDA UDI
Class IActive
Abx Pentra Potassium-E 3014029450
FDA UDI
Class IIActive
Abx Pentra Cholesterol Cp 1220001634
FDA UDI
Class IActive
Abx Pentra Hba1c Wb, Calibrator, Control And Hemolysis Reagent K073309
FDA 510(k)
Class IIActive
Abx Pentra Glucose Hk Cp, Urea Cp, Uric Acid Cp K070146
FDA 510(k)
Class IIActive
Chromopep Pc, Chromopep At, Models 2.5 And 5 K050448
FDA 510(k)
Class IIActive
Abx Erytrol K050721
FDA 510(k)
Class IIActive
Abx Pentra 400: Lipoproteins K060854
FDA 510(k)
Class IIActive
Abx Pentra 400 : Crp K061138
FDA 510(k)
Class IIActive
Abx Pentra Amylase Cp; Multical; N Control; P Control; Clean-Chem Cp; Clean-Chem 99 Cp K062180
FDA 510(k)
Class IIActive
Abx Pentra Bilirubin, Direct Cp, Abx Pentra Bilirubin, Total Cp, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P K060325
FDA 510(k)
Class IIActive
Hepatic Enzymes On Abx Pentra 400 Clinical Chemistry Analyzer K060318
FDA 510(k)
Class IIActive
Abx Pentra 400 Clinical Chemistry Analyzer (option: I.s.e. Module) K052007
FDA 510(k)
Class IIActive
Abx Micros Crp 200, Option Im K053308
FDA 510(k)
Class IIActive
Cardiac Markers On Abx Pentra 400 Clinical Chemistry Analyzer K062737
FDA 510(k)
Class IIActive
General Chemistries On Abx Pentra 400 Clinical Chemistry Analyzer K060205
FDA 510(k)
Class IIActive
Abx Pentra Albumin Cp, Abx Pentra Micro-Albumin Cp, Abx Pentra Total Protein Cp, Abx Pentra Multical K060434
EUDAMEDFDA 510(k)FDA UDI
Class IIActive
Abx Pentra Creatinine 120 Cp, Total Protein 100 Cp, Multical, N And P Controls, And Urine Control L/H K072115
FDA 510(k)
Class IIActive
Abx Pentra Urine Cal K071779
FDA 510(k)
Class IIActive
Abx Pentra 400, Calcium Cp, Creatinine Cp, Phosphorus Cp, Amylase Cp, Urine Control L/H K070249
FDA 510(k)
Class IIActive
Abx Pentra Dx 120: Option Sps Evolution K050719
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.