Abbott Laboratories
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000017778 FEI 3005333358
- Devices
- 1,527
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
A-Gent Urea Nitrogen Ref K810794
Axsym Progesterone Ref K955025
Lcx Neisseria Gonorrhoeae Assay Ref K935833
Aspartate Aminotransferase (Ast) Ref K981225
Abbott Testpack(Tm) Chlamydia Positive Control Ref K882535
3-Way Stopcock W/Male Locking Luer Ada. Ref K791914
Adx Amphetamine/Methampheamine Ref K890692
Abbott Testpack(Tm) D-Dimer Ref K890422
Dbil Ref K981943
Pancretec I.V. Model 5000 Infuser Ref K895867
Abbott Testpack Plus Tm Hcg-Combo Ref K903219
Vision(R) Total Bilirubin With A Neonatal Claim Ref K880437
Igg Ref K983221
Abbott Imx Ige Ref K895914
Ivex-Hp Pediatric Extension Set-Sl Ref K821013
Venoset For I.V. Fat Emulsion Ref K770051
Lifeshield Extension Set Ref K912103
Barbiturates Ref K012996
Iv Set That Reverts To Kvo Rate Ref K770744
Receptal (R) Saf-Gard(Tm) Suction Liner Ref K893741
Hand Controlled Syringe Ref K942329
Bioassay System, Ms-2 Serum Ref K782049
Tdx Methadone Assay Ref K884968
Abbott Axsym Troponin-I Ref K974103
Cell-Dyn Sapphire System Ref K051215
Primary Piggyback Venoset W/ Filter Ref K771594
Abbott Architect B12 Ref K984108
Abbott Laboratories Strep A Eia Ref K823569
Abbott Imx Free T4 Ref K902834
Abbott Architect Free T4 Ref K983417
Tdx Analyzer W/Nephelometry Carousel Ref K851253
Imx Follicle Stimulating Hormone (Fsh) Ref K890135
Winged Catheter Ref K830765
Ms-2 Bacterial Identi. Sys Ref K830099
Abbott Lte Infusion Pump Ref K944125
Axsym(Tm) Quinidine Ref K940682
Imx Free Triiodothyronine Ref K905261
Lifecare 4/Homecare - 4H Pump Ref K840263
Snapdose Device Ref K955410
Fact Plus One Step Pregnancy Test Ref K990373
Flexiflo Laparoscopic Gastrostomy Kit Ref K924697
Obturator Ref K770404
Axsym Total T3 Ref K934517
Methadone Ref K013001
Abbott Cmv-M Eia Kit Ref K872881
Bichromatic Analyzer Aba-200 Ref K771345
HAVAb IgG II Ref K222850
Abbott Testpack(Tm) Rsv Positive Control Ref K882277
Ferrizyme Ferritin Enzyme Immunoassay Ref K801676
Showing 851-900 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.