Abbott Laboratories
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000017778 FEI 3005333358
- Devices
- 1,527
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Tdx Free T3 Calculation Ref K903433
Imx Ckmb Ref K883013
Abbott Plum A+infusion Pump, Model 11971 Ref K011442
Cardiac Catherization Kit Ref K914299
Axsym Digoxin Ii Ref K953718
Axsym Luteinizing Hormone (Lh) Ref K935611
Acclaim Infusion Pump Ref K991501
Amy Ref K981653
Abbott Axsym System Ref K974651
A-Gent Phenobarbital Ref K832457
Tdx Amylase Ref K853978
Abbott Inpersol Cycler 1000 Ref K845042
Tdx C-Reactive Protein Ref K854542
Uric Acid Ref K981189
Vision(R) Crp Ref K875345
Pocket Manometer Ref K880599
Inpersol Capd Bag Port Clamp Ref K803300
Abbott Architect Ferritin Ref K983759
Continuous Cardiac Output System Ref K932414
Sutureless Skin Closure Ref K780565
Lifecare Plumset Vented Secondary I.V. Set Ref K933326
Glu Ref K981185
Alinity C Glucose Reagent Kit, Alinity C System Ref K170316
Lifecare(R) 175 Infuser Ref K900057
Imx Select Analyzer Ref K912368
Abbott Spectrum Phosphorus Reagent Ref K863088
A-Gent Immunoglobuline Test System Ref K790479
Chemkit Carbamazepine Diagnostic Kit Ref K834052
Cybrex Amikacin Ref K802669
Abbott Architect Tsh Ref K983442
Needle Connecting Set, Blunt Ref K780105
Multiconstituent Calibrator Ref K103403
Vision Total Protein Ref K861798
Chemkit Phenytoin Diag. Kit Ref K833806
Abbott B2-Microglobulin Ria Ref K864130
Pro Quantum Ref K831249
Inpersol Capd Admin. Set & Catheter Adap Ref K800993
Ivex-2 Extension Set With Y-Injection Site Ref K941684
A-Gent Liquid Albumin Ref K860423
Axsym Follicle Stimulating Hormone (Fsh) Ref K935612
CO2 Ref K981840
Abbott Architect Total T4 Ref K983440
Eia Processor Ref K854936
Vision Phenytoin Ref K896074
Revised Labeling For Adx Cannabinoids Ref K880015
Modified Lifecare(R) 4100 Pca Infuser Ref K871728
Tdx R Opiates Ref K854421
Showing 951-1,000 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.