Company
Cell Marque Corporation
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
18recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MVU | Reagents, Specific, Analyte | 7 |
| NJT | Immunohistochemistry Reagents And Kits | 4 |
| LKC | Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus | 2 |
| NYQ | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer | 2 |
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | 1 |
| OPL | Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus | 1 |
| OWF | Immunohistochemical Assay, Helicobacter Pylori | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2021 | Cell Marque Corporation Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16 Open, Classified |
NJT | None listed |
| May 27, 2021 | Cell Marque Corporation Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513 Terminated |
MVU | None listed |
| May 27, 2021 | Cell Marque Corporation Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798 Terminated |
MVU | None listed |
| Jun 1, 2017 | Cell Marque Corporation 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 Terminated |
MVU | None listed |
| Jun 1, 2017 | Cell Marque Corporation 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 Terminated |
MVU | None listed |
| Jun 1, 2017 | Cell Marque Corporation Varicella Zoster Virus
7.0 ml catalog number 364M-18
Microbiology - Analyte Specific Reagent
In vitro diagnostic use - Analyte Specific Reagent Terminated |
OPL | None listed |
| Jun 1, 2017 | Cell Marque Corporation SV40 (MRQ-4)
0.5 ml catalog number 351 M-15.
Microbiology - Analyte Specific Reagent
In vitro diagnostic use - Analyte Specific Reagent Terminated |
MVU | None listed |
| Jun 1, 2017 | Cell Marque Corporation 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 Terminated |
LKC | None listed |
| Jun 1, 2017 | Cell Marque Corporation Herpes Simplex Virus I;
7.0 mL Catalog number 361A-18.
Microbiology - Analyte Specific Reagent
In vitro diagnostic use - Analyte Specific Reagent Terminated |
LKC | None listed |
| Jun 1, 2017 | Cell Marque Corporation 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 Rea Terminated |
NYQ | None listed |
| Jun 1, 2017 | Cell Marque Corporation 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 Terminated |
NYQ | None listed |
| Jun 1, 2017 | Cell Marque Corporation H. pylori (polyclonal}
1.0 mL Catalog number 215A-76;
Hematology - Analyte Specific Reagent
In vitro diagnostic use - Analyte Specific Reagent Terminated |
OWF | None listed |
| Jun 1, 2017 | Cell Marque Corporation Estrogen Receptor (SP1)
7.0 mL Catalog number 249R-18;
Hematology - Analyte Specific Reagent
In vitro diagnostic use - Analyte Specific Reagent Terminated |
MVU | None listed |
| Jun 1, 2017 | Cell Marque Corporation 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 Terminated |
MVU | None listed |
| Jun 1, 2017 | Cell Marque Corporation 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 Terminated |
GOD | None listed |
| May 10, 2016 | Cell Marque Corporation 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 s Terminated |
NJT | K133845 |
| Mar 6, 2012 | Cell Marque Corporation 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 Terminated |
NJT | None listed |
| Aug 31, 2011 | Cell Marque Corporation 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 l Terminated |
NJT | None listed |