32 results · 37ms · Sources: EU EUDAMED, US FDA

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Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798

FDA Recall
Terminated ·Cell Marque Corporation·Product code MVU·May 27, 2021

Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513

FDA Recall
Terminated ·Cell Marque Corporation·Product code MVU·May 27, 2021

Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Recall
Terminated ·Cell Marque Corporation·Product code MVU·May 5, 2017

SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Recall
Terminated ·Cell Marque Corporation·Product code MVU·May 5, 2017

Cell Marque antibody CD99 (H036-1.1) Mouse Monoclonal Antibody. Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677 The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded tissue sections using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist of physician.

FDA Recall
Terminated ·Cell Marque Corporation·Product code NJT·July 12, 2011

HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Recall
Terminated ·Cell Marque Corporation·Product code MVU·May 5, 2017

Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Recall
Terminated ·Cell Marque Corporation·Product code MVU·May 5, 2017

Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number362A-18 . Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Recall
Terminated ·Cell Marque Corporation·Product code LKC·May 5, 2017

H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Recall
Terminated ·Cell Marque Corporation·Product code OWF·May 5, 2017

Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Recall
Terminated ·Cell Marque Corporation·Product code NYQ·May 5, 2017

CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Recall
Terminated ·Cell Marque Corporation·Product code MVU·May 5, 2017

Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent

FDA Recall
Terminated ·Cell Marque Corporation·Product code NYQ·May 5, 2017

Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Recall
Terminated ·Cell Marque Corporation·Product code GOD·May 5, 2017

Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Recall
Terminated ·Cell Marque Corporation·Product code OPL·May 5, 2017

SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods.

FDA Recall
Terminated ·Cell Marque Corporation·Product code NJT·May 10, 2016

Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Recall
Terminated ·Cell Marque Corporation·Product code LKC·May 5, 2017

Cell Marque CD7 (MRQ-12); Mouse Monoclonal Antibody, Antibody is bottle in HDPE bottle with screw cap lid with container label. Then put in cardboard Box with outer box label. Cell Marque, Rocklin, CA 95677, intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in section of formalin fixed, paraffin embedded tissue section using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist or physician.

FDA Recall
Terminated ·Cell Marque Corporation·Product code NJT·January 23, 2012

Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Enforcement
Class II ·Terminated·Cell Marque Corporation·June 7, 2017

Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Enforcement
Class II ·Terminated·Cell Marque Corporation·June 7, 2017

Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent

FDA Enforcement
Class II ·Terminated·Cell Marque Corporation·June 7, 2017