Abbott Laboratories
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000017778 FEI 3005333358
- Devices
- 1,527
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Provider Anne Infuser Ref K922702
Tdx Rea Lactic Acid Ref K861741
Cell-Dyn Ruby System Ref K061667
Cell-Dyn 4000 Immuno T-Cell (CD3/4/8) Assay Ref K010953
Chlamydiazyme/Commander Instrumentation Ref K885006
Nitroglycerine Iv Set Ref K810317
Imx Free T3 Calculation Ref K903432
Abbott Imx Glycated Hemoglobin Ii Ref K992085
Vented Nitroglycerin I.V. Set Ref K821515
Revised Labeling For Tdx Cannabinoids Ref K874488
A-Gent Liquid Total Protein Ref K860426
Calcium Ref K062855
Cocaine Ref K013004
Abbott Rsv Eia Ref K862429
Flexiflo Quantum Enteral Nutrition Pump Ref K913958
Abbott Axsym Troponin-I Adv Ref K041811
Nebulizer Tubing Set Ref K800083
A-Gent(Tm) Liquid Glucose Trinder Ref K863948
Alinity i Rubella IgG Ref K243168
Abbott Architect Cea Ref K990774
Tidal Distension Irrigation Set Ref K841362
Chem Kit Phenobarbital Ref K833796
Pri. Piggyback I.V. W/Dual Piercing Pin Ref K800137
Abbott Spectrum Glucose Reagent Ref K864224
Abbott Htsh Eia Diagnostic Kit Ref K843540
Tdx Cocaine Metabolite Ref K854163
Cybrex Lidocaine Ref K802131
Abbott Rf Eia Diagnostic Kit Ref K850373
Vista Instrument Ref K882914
Abbott Architect Folate Ref K023397
Abbott Hcg Serum Controls Ref K970527
Tdx(R)/Tdx(R)Flx(R)Mehtotrexate Ii Ref K932615
Imx Toxo Igm Antibody Assay Ref K890032
The Abbott Executive Ref K790543
Iron Ref K981241
Imx Cmv Igg Antibody Assay Ref K900474
Abbott Cell-Dyn 3000 Series Hematology Systems Ref K980614
Axsym Digitoxin Ref K954420
Inpersol Capd Biocap Administration Set Ref K911094
Flexiflo Nasoenteric Feeding Tube Ref K922217
Showing 901-950 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.