Abbott Laboratories
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000017778 FEI 3005333358
- Devices
- 1,527
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Chlamydiazyme Diagnostic Kit Ref K864842
Capd Color-Guard System Prepkit Ref K830002
Abbott Testpack Hcg(Urine) Diagnostic Kit Ref K853539
Imx Total B-Hcg Ref K894182
Pressure Infusion Cuff Ref K781556
Y-Type Blood Set Ref K780880
Creatinine (Crea) Ref K981240
Vision (Tm) Calcium Ref K863670
A-Gent Triglycerides Ref K771608
Axsym Tobramycin Ref K941614
T3 Riabead Diagnostic Kit Ref K803261
Axsym Methadone Ref K953499
Abbott Axsym Troponin-I Adv Ref K060875
Tdx Tm Streptomycin Ref K821136
Ivex-Tpn Extension Filter Set Ref K913308
Tdx Salicylate Ref K844070
Tdx(R) Ii Analyzer Ref K864319
Vision Lyte (Tm) Potassium Ref K884566
Imx Hcg (List #03A63) Ref K900327
Dye Management System Ref K933700
Hi-Flo Infusion Pump Ref K934671
Abbott Vision Theophylline Iia Ref K926245
Plum Xl Infusion Pump (Modification) Ref K953660
Axsym Barbiturates Ii U Ref K951253
Adx(Tm) Analyzer Ref K864566
Abbott Commander Parallel Processing Center Ref K897158
Toxo-G Eia Diagnostic Kit Ref K840879
Trf Ref K983167
Abbott Strep A Controls Ref K922490
Magnesium Ref K173294
Activated Aspartate Aminotransferase Ref K071525
Tdx Ethosuximide Ref K850174
Axsym Cannabinoids Ref K951288
Vision Sgot (Ast) Ref K854982
ARCHITECT 2nd Generation Testosterone Ref K152155
Tdx Thyroxine Ref K830683
Rotazyme Ref K791746
Axsym Toxo Igm Ref K954576
Axsym Cmv Igg Antibody Assay Ref K953943
Ultracare(Tm) Automated Patient Assist Device Ref K874020
Abbott Strep A P.S.D. Ref K852266
Vision(R) Thyroxine (T4) Ref K880662
Abbott Laboratories Prolactin Eia Ref K822759
Pda Glucose Ref K843541
Flexiflo Six Enteral Nutrition Pump Set Ref K943240
Imx Cmv Igm Antibody Assay Ref K900473
Showing 751-800 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
1 more person
- David Birdow
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.