BEUDAMED
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    Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)

    FDA Enforcement
    Class III ·Ongoing·Helena Laboratories, Corp.·December 4, 2019

    Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,

    FDA Enforcement
    Class III ·Ongoing·Helena Laboratories, Corp.·December 4, 2019

    Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds to cyclin/CDK complexes and inhibits their kinase activity thereby stopping cell cycle progression. It also binds to PCNA (proliferating cell nuclear antigen) and blocks DNA replication but not the DNA repair process. Product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.

    FDA Enforcement
    Class III ·Terminated·Lab Vision Corporation·December 2, 2015

    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d. 20mL Oral Syringe Amber NonSterile, Product Code BA-S20EO; e. 35mL Oral Syringe Amber NonSterile, Product Code BA-S35EO; f. 3mL Oral Syringe Amber NonSterile, Product Code BA-S3EO; g. 60mL Oral Syringe Amber NonSterile, Product Code BA-S60EO; h. 6mL Oral Syringe Amber NonSterile, Product Code BA-S6EO;

    FDA Enforcement
    Class III ·Ongoing·Avanos Medical, Inc.·June 19, 2024

    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange NonSterile, Product Code BC-S12EO; c. 1mL Oral Syringe Orange NonSterile, Product Code BC-S1EO; d. 20mL Oral Syringe Orange NonSterile, Product Code BC-S20EO; e. 35mL Oral Syringe Orange NonSterile, Product Code BC-S35EO; f. 3mL Oral Syringe Orange NonSterile, Product Code BC-S3EO; g. 60mL Oral Syringe Orange NonSterile, Product Code BC-S60EO; h. 6mL Oral Syringe Orange NonSterile, Product Code BC-S6EO

    FDA Enforcement
    Class III ·Ongoing·Avanos Medical, Inc.·June 19, 2024

    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d. 20mL Oral Syringe Blue NonSterile, Product Code BB-S20EO; e. 35mL Oral Syringe Blue NonSterile, Product Code BB-S35EO; f. 3mL Oral Syringe Blue NonSterile, Product Code BB-S3EO; g. 60mL Oral Syringe Blue NonSterile, Product Code BB-S60EO; h. 6mL Oral Syringe Blue NonSterile, Product Code BB-S6EO;

    FDA Enforcement
    Class III ·Ongoing·Avanos Medical, Inc.·June 19, 2024

    VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, and PHYT.

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics·November 11, 2015

    Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only

    FDA Enforcement
    Class III ·Terminated·Medtest Holdings, Inc.·July 5, 2017