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CELL MARQUE CORPORATION

United States·US-MF-000028332

Last updated September 17, 2026

Information

Country: United States
Address: 6600, Sierra College Blvd, Rocklin, United States
Website: cellmarque.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 916 746 8900
PRRC Contact: Cheryl Prichard
EUDAMED SRN: US-MF-000028332
FDA FEI Number: 3017212430
DUNS Number: 025048773

Catalogue (2151)

Page 35 of 44

Device	Model / Reference	Registries	Class	Status
Her2/Neu (SP3) Rabbit Monoclonal Antibody	237R-14-ASR	FDA UDI	Class I	Active
CA 125 (OC125) Mouse Monoclonal Antibody	325M-18	FDA UDI	Class I	Active
Fascin (55k-2) Mouse Monoclonal Antibody	252M-18	FDA UDI	Class I	Active
CD13 (SP187) Rabbit Monoclonal Antibody	113R-14	FDA UDI	Class I	Active
EZH2 (11) Mouse Monoclonal Antibody	415M-18	FDA UDI	Class I	Active
Adipophilin Rabbit Polyclonal Antibody	393A-17	FDA UDI	Class I	Active
Galectin-3 (9C4) Mouse Monoclonal Antibody	760-4256	FDA UDI	Class I	Active
Inhibin, alpha (MRQ-63) Rabbit Monoclonal Antibody	271R-24	FDA UDI	Class I	Active
IgM Rabbit Polyclonal Antibody	270A-18	FDA UDI	Class I	Active
CD3 (MRQ-39) Rabbit Monoclonal Antibody	103R-94	FDA UDI	Class I	Active
CD20 (SP32) Rabbit Monoclonal Antibody	120R-17	FDA UDI	Class I	Active
CD163 (MRQ-26) Mouse Monoclonal Antibody	760-4437	EUDAMEDFDA UDI	Class I	Active
Glypican-3 (1G12) Mouse Monoclonal Antibody	261M-95	EUDAMEDFDA UDI	Class I	Active
Factor VIII-R Ag. Rabbit Polyclonal Antibody	250A-14	FDA UDI	Class I	Active
Gastrin Rabbit Polyclonal Antibody	760-2643	FDA UDI	Class I	Active
Heat Shock Protein 70 (EP377) Rabbit Monoclonal Primary Antibody	460R-15	FDA UDI	Class I	Active
Collagen Type IV (CIV22) Mouse Monoclonal Antibody	760-2632	FDA UDI	Class I	Active
Herpes Simplex Virus II (3C5.2) Mouse Monoclonal Antibody	362M-15-ASR	FDA UDI	Class I	Active
Calretinin (SP13) Rabbit Monoclonal Antibody	232R-18	FDA UDI	Class I	Active
Neurofilament (2F11) Mouse Monoclonal Antibody	302M-18	FDA UDI	Class I	Active
Cyclin D1 (EP12) Rabbit Monoclonal Primary Antibody	241R-48	FDA UDI	Class I	Active
Inhibin, alpha (MRQ-63) Rabbit Monoclonal Primary Antibody	760-6081	FDA UDI	Class I	Active
PAX-5 (EP156) Rabbit Monoclonal Primary Antibody	312R-24	FDA UDI	Class I	Active
Epstein-Barr Virus (MRQ-47) Rabbit Monoclonal Antibody	245R-18-ASR	FDA UDI	Class I	Active
Prolactin Rabbit Polyclonal Antibody	210A-14	FDA UDI	Class I	Active
MUC1 (MRQ-17) Mouse Monoclonal Antibody	290M-16	FDA UDI	Class I	Active
MLH1 (G168-728) Mouse Monoclonal Antibody	285M-16	FDA UDI	Class I	Unknown
IgG Rabbit Polyclonal Antibody	269A-15	FDA UDI	Class I	Active
CDK4 (DCS-31) Mouse Monoclonal Antibody	478M-98	FDA UDI	Class I	Unknown
Chromogranin A (LK2H10) Mouse Monoclonal Antibody	238M-90	FDA UDI	Class I	Active
CD3 Rabbit Polyclonal Antibody	103A-75	FDA UDI	Class I	Active
Calponin (CALP) Mouse Monoclonal Antibody	231M-15	FDA UDI	Class I	Active
Hemoglobin A (EPR3608) Rabbit Monoclonal Primary Antibody	360R-15	FDA UDI	Class I	Active
CD79a (SP18) Rabbit Monoclonal Antibody	179R-18	FDA UDI	Class I	Active
MUM1 (MRQ-8) Mouse Monoclonal Antibody	358M-15	FDA UDI	Class I	Active
ARID1A (EP303) Rabbit Monoclonal Primary Antibody	407R-14-ASR	FDA UDI	Class I	Unknown
FOXP1 (EP137) Rabbit Monoclonal Primary Antibody	350R-25	FDA UDI	Class I	Active
CD1a (EP3622) Rabbit Monoclonal Primary Antibody	101R-16	FDA UDI	Class I	Active
PSMA (EP192) Rabbit Monoclonal Primary Antibody	760-6076	FDA UDI	Class I	Active
GH Rabbit Polyclonal Antibody	208A-78	FDA UDI	Class I	Active
MUM1 (MRQ-8) Mouse Monoclonal Antibody	358M-14	FDA UDI	Class I	Active
Macrophage (HAM-56) Mouse Monoclonal Antibody	279M-16	FDA UDI	Class I	Active
Ki-67 (MRQ-64) Rabbit Monoclonal Antibody	275R-34	FDA UDI	Class I	Unknown
Nestin (10C2) Mouse Monoclonal Antibody	388M-17	FDA UDI	Class I	Active
Hepatocyte Specific Antigen (Hep-Par1) (EP265) Rabbit Monoclonal Primary Antibod	264R-15	FDA UDI	Class I	Active
TRAcP (9C5) Mouse Monoclonal Antibody	341M-98	FDA UDI	Class I	Active
BCL2 (E17) Rabbit Monoclonal Primary Antibody	226R-18	FDA UDI	Class I	Active
A-1-Antichymotrypsin Rabbit Polyclonal Antibody	222A-14	FDA UDI	Class I	Active
PAX-8 (EP331) Rabbit Monoclonal Primary Antibody	760-6077	FDA UDI	Class I	Active
TAG-72 (B72.3) Mouse Monoclonal Antibody	760-2669	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (18)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 15, 2021	Z-2311-2021	—	open, classified	Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.
May 27, 2021	Z-2105-2021	—	terminated	Product distributed for use as an In-vitro Diagnostics without FDA clearance
May 27, 2021	Z-2106-2021	—	terminated	Product distributed for use as an In-vitro Diagnostics without FDA clearance
May 5, 2017	Z-2204-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2209-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2203-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2199-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2200-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2205-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2202-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2201-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2207-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2206-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2210-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2208-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 10, 2016	Z-2038-2016	—	terminated	Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result.
Jan 23, 2012	Z-1176-2012	—	terminated	Letter received from supplier that material received in October 2009 was labeled as CD7, but was actually CD 2.
Jul 12, 2011	Z-3110-2011	—	terminated	Incorrect label on product bottle, although labeling on outer box is correct.