Abbott Laboratories

United States US-MF-000017777 Last updated 25 Oct 2026

Devices: 1,527
Registries: EUDAMEDFDA PMAFDA
FDA recalls: 0

Catalogue1,527

Page 31 of 31

Pgr-Eia Monoclonal Ref P900013

Class III FDA PMA Active
Abbott Er-Eia Monoclonal Diag. Kit Ref P850029

Class III FDA PMA Active
Murine Contact Lens Cleaner Ref P880052

Class II FDA PMA Active
Axsym Anti-Hcv (Ln 5C36) Ref P970027

Class II FDA PMA Active
Abbott Afp Ref P780005

Class III FDA PMA Active
Abbott Er-Ica Monoclonal Ref P880026

Class III FDA PMA Active
Abbott Axsym Afp Ref P820060

Class II FDA PMA Active
Cea--Ria Dixgnostic Test Kit Ref P800056

Class II FDA PMA Active
Ms 2 Automated System Ref N60242

Class II FDA PMA Active
Abbott Anti-Delta Diagnostic Kit (Ria) Ref P850062

Class III FDA PMA Active
Anti-Carcinoembryonic Antigen (Goat) Cea Ria Ref P800005

Class II FDA PMA Active
ARCHITECT AFP, Alinity i AFP Ref P120008

Class III FDA PMA Active
ARCHITECT HBsAg Next Qualitative/Next Confirmatory Ref P210003

Class II FDA PMA Active
Imx Havab Ref P780012

Class II FDA PMA Active
Architect Hbsag/Hbsag Confirmatory Ref P060007

Class II FDA PMA Active
Freestyle Navigator Continuous Glucose Monitoring System Ref K060383

Class III FDA PMA Active
Murine Lubricating & Rewetting Drops(Clear Eyes ) Ref P880056

Class II FDA PMA Active
Architect Hbsag Qualitative/Hbsag Qualitative Confirmatory Ref P110029

Class II FDA PMA Active
Architect Core Reagent Kit, Architect Core Calibrator And Architect Core Controls Ref P080023

Class II FDA PMA Active
Abbott Havab -M Eia Ref P790019

Class II FDA PMA Active
ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit Ref K983132

Class II FDA PMA Active
Abbott Hbe Diagnostic Kit Ref P790025

Class II FDA PMA Active
ARCHITECT Free PSA Reagent Kit, Alinity i Free PSA Reagent Kit Ref P980007

Class III FDA PMA Active
Abbott Cea-Eia Ref P830066

Class II FDA PMA Active
Abbott Imx(R) Psa* Ref P910007

Class II FDA PMA Active
Antimicrobial Susceptability Test System Ref N50525

Class II FDA PMA Active
Tdx Cyclosporine And Metabolites Serume Assay Ref P890025

Class II FDA PMA Active

Showing 1,501-1,527 of 1,527

What Abbott Laboratories makes

Abbott Laboratories manufactures diagnostic test kits, including the ThyroidScreen™ T4 diagnostic kit and TDX assays for detecting substances like amphetamines and cannabinoids, as well as laboratory reagents such as ALKP and AST additives for blood testing. The company also produces infusion pumps, including the Abbott Plum A+ with HPL/RS plug-and-play modules, and specialized medical devices like the Modified Lifecare Model 175 infuser and the Regulator Venoset with integrated filtration. Cardiac monitoring solutions include the Cardiac Output Thermodilution Module, and identification systems like the MS-2 IDENTIFICATION SYSTEM are part of its portfolio. Burn care products, such as the Hydron Burn Disposable Dispenser Set, and labeling submissions for regulated substances are also offered.

These devices are regulated under the FDA’s 510(k) pathway, with classifications spanning Class I, Class II, and Unclassified (U). The company’s products are listed in the FDA’s 510(k) clearance registry, reflecting their compliance with U.S. medical device regulations. Abbott Laboratories operates as a U.S.-based manufacturer.

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

Information

Country: United States(from SRN)
Address: 1921, Hurd Drive, Irving, United States
Website: abbott.com
Email: [email protected]
Phone: +1(877)422-2688
PRRC contact: Jonathan Requejo
EUDAMED SRN: US-MF-000017777
FDA FEI number: 3005333358
DUNS number: 079226220

Catalogue1,527

Pgr-Eia Monoclonal Ref P900013

Abbott Er-Eia Monoclonal Diag. Kit Ref P850029

Murine Contact Lens Cleaner Ref P880052

Axsym Anti-Hcv (Ln 5C36) Ref P970027

Abbott Afp Ref P780005

Abbott Er-Ica Monoclonal Ref P880026

Abbott Axsym Afp Ref P820060

Cea--Ria Dixgnostic Test Kit Ref P800056

Ms 2 Automated System Ref N60242

Abbott Anti-Delta Diagnostic Kit (Ria) Ref P850062

Anti-Carcinoembryonic Antigen (Goat) Cea Ria Ref P800005

ARCHITECT AFP, Alinity i AFP Ref P120008

ARCHITECT HBsAg Next Qualitative/Next Confirmatory Ref P210003

Imx Havab Ref P780012

Architect Hbsag/Hbsag Confirmatory Ref P060007

Freestyle Navigator Continuous Glucose Monitoring System Ref K060383

Murine Lubricating & Rewetting Drops(Clear Eyes ) Ref P880056

Architect Hbsag Qualitative/Hbsag Qualitative Confirmatory Ref P110029

Architect Core Reagent Kit, Architect Core Calibrator And Architect Core Controls Ref P080023

Abbott Havab -M Eia Ref P790019

ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit Ref K983132

Abbott Hbe Diagnostic Kit Ref P790025

ARCHITECT Free PSA Reagent Kit, Alinity i Free PSA Reagent Kit Ref P980007

Abbott Cea-Eia Ref P830066

Abbott Imx(R) Psa* Ref P910007

Antimicrobial Susceptability Test System Ref N50525

Tdx Cyclosporine And Metabolites Serume Assay Ref P890025

What Abbott Laboratories makes

Information