Abbott Laboratories
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000017778 FEI 3005333358
- Devices
- 1,527
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
5UM Filterset With Y-Injection Site Ref K771972
Tdx(R)/Tdxflx(R) Free Phenytoin Ii Ref K950280
Abbott A-Gent Liquid Magnesium Reagent Ref K872311
Tdx Immunoglobulin M Diagnostic Kit Ref K854944
Abbott Imx T3 Ref K880087
Cell-Dyn 1200 System Ref K991142
Amm Ref K981920
Tdx Cortisol Ref K854419
Phosphorus (Inorganic) Analysis Products Ref K781000
Vision Theophylline Ii Ref K896927
Abbott Architect Free T3 Ref K983439
Central Station Monitoring System Ref K761291
Ms-2 Automated Urine Screening System Ref K781370
Vision (Tm) Ggtp Ref K864208
Ast Ref K983131
Abbott Spectrum Glucose-Hexokinase Reagent Ref K894394
Capd Staged Connector Ref K845041
Carbon Dioxide Ref K060295
Alinity h-series System Ref K220031
Gono-Cell Ref K782013
Imx Ca 15-3 Ref K964407
Axsym Carbamazephine Ref K935374
Albg Ref K981468
Axsym Vancomycin Ii Ref K955851
Tdx Barbiturates Serum Ref K892650
Benzodiazepines Ref K013143
Axsym Phencyclidine Ii Ref K953534
Chem Kit Theophylline Diag. Kit Ref K833683
Abbott Pap-Eia Ref K873903
Ast Ref K981843
Ualb Ref K983774
Abbott Ovulation Predictor Test Ref K890510
Axsym Phenytoin Assay Ref K935375
Abbott Imx Toxo Igm Positive Control Ref K913106
Creatine Kinase (Ck) Ref K981218
Abbott ARCHITECT Total T4 Calibrators Ref K151566
Inpersol-Capd Adminis. Set Type Dp Ref K822712
Vision(R) Ldh (Lactate Dehydrogenase) Ref K881474
Modification To Plum Xl Infusion Pump Ref K010924
Cell-Dyn Emerald System Ref K081495
Abbott Imx T4 Ref K925110
A-Gent Quantichrom Thrombigen-E Ref K800656
Crea Ref K981799
Htsh Ria Ref K780122
A-Gent Thyrozyme Uptake Inhibitor Assay Ref K800911
Tdx Ethanol Ref K840826
Prolactin Ria Diag. Kit Ref K771656
Showing 1,151-1,200 of 1,527
Company details
- EUDAMED SRN
- US-MF-000017778
- FDA FEI number
- 3005333358
- DUNS number
- 079226220
- EUDAMED status
- Active
- EUDAMED registered name
- Abbott Laboratories
- EUDAMED abbreviated name
- Abbott Dallas LC8
- Registered address
- 1921, Hurd Drive, 75038, Irving, United States
- Website
- www.abbott.com
- [email protected]
- Phone
- +1 (972) 518-6000
- PRRC contact
- Jonathan Requejo
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.