12 results
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21ms
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Sources: EU EUDAMED, US FDA
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