12 results · 21ms · Sources: EU EUDAMED, US FDA

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meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.

FDA Enforcement
Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·March 2, 2022

Michels Transport Medium, 20ML Prefilled Cont

FDA Enforcement
Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·March 2, 2022

ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

FDA Enforcement
Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·June 1, 2022

Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.

FDA Enforcement
Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·April 13, 2022

HARDY DIAGNOSTICS CatScreen, 25dsk/vial

FDA Enforcement
Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·February 9, 2022

Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)

FDA Enforcement
Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·April 20, 2022

Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605

FDA Enforcement
Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·December 29, 2021

Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.

FDA Enforcement
Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·April 20, 2022

Premier Rotaclone, Rx only

FDA Enforcement
Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·February 9, 2022

Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box

FDA Enforcement
Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·April 20, 2022

VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.

FDA Enforcement
Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·October 19, 2022

CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545

FDA Enforcement
Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·October 26, 2022