8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
FDA Enforcement
Class II
·Ongoing·Helena Laboratories, Corp.·June 28, 2023
V8 Immunodisplacement Kit REF 1803
FDA Enforcement
Class II
·Ongoing·Helena Laboratories, Corp.·June 15, 2022
ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
FDA Enforcement
Class II
·Ongoing·Helena Laboratories, Corp.·July 17, 2019
ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
FDA Enforcement
Class II
·Ongoing·Helena Laboratories, Corp.·July 17, 2019
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
FDA Enforcement
Class II
·Terminated·Helena Laboratories, Corp.·October 16, 2019
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
FDA Enforcement
Class II
·Terminated·Helena Laboratories, Corp.·October 9, 2019
K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
FDA Enforcement
Class II
·Ongoing·Helena Laboratories, Corp.·December 23, 2020
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
FDA Enforcement
Class II
·Terminated·Helena Laboratories, Corp.·February 17, 2021