14 results · 14ms · Sources: EU EUDAMED, US FDA

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CMV IgM EIA, in vitro diagnostic.

FDA Recall
Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LFZ·October 19, 2022

HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114.

FDA Recall
Open, Classified ·Hycor Biomedical LLC·Product code DHB·July 25, 2018

Total Thyroxine (T4) ELISA; REF EIA-1781

FDA Recall
Open, Classified ·DRG International, Inc.·Product code KLI·October 18, 2021

Parvovirus B19 IgG EIA kit Part No. V519IGUS

FDA Recall
Open, Classified ·Diasorin Inc.·Product code MYL·July 17, 2020

Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA

FDA Recall
Open, Classified ·DRG International, Inc.·Product code CDX·June 4, 2025

17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292

FDA Recall
Open, Classified ·DRG International, Inc.·Product code JLX·September 13, 2024

MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above

FDA Recall
Open, Classified ·Quidel Corporation·Product code DBA·February 1, 2023

HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.

FDA Recall
Open, Classified ·Hycor Biomedical Inc·Product code DHR·March 19, 2018

Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.

FDA Recall
Open, Classified ·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025

Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

FDA Recall
Open, Classified ·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025

Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)

FDA Recall
Open, Classified ·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025

Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)

FDA Recall
Open, Classified ·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025

ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009

FDA Recall
Open, Classified ·LEONI CIA CABLE SYSTEMS 5 avenue Victor Hugo Chartres France·Product code JAI·October 6, 2023

ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003

FDA Recall
Open, Classified ·LEONI CIA CABLE SYSTEMS 5 avenue Victor Hugo Chartres France·Product code JAI·October 6, 2023