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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 9 of 44

Device	Model / Reference	Registries	Class	Status
TCL1 (MRQ-7) Mouse Monoclonal Antibody	357M-18	FDA UDI	Class I	Active
CD35 (EP197) Rabbit Monoclonal Primary Antibody	135R-16	FDA UDI	Class I	Active
Ksp-Cadherin (MRQ-33) Mouse Monoclonal Antibody	760-4387	FDA UDI	Class I	Active
HHV-8 (13B10) Mouse Monoclonal Antibody	265M-15-ASR	FDA UDI	Class I	Active
Cytokeratin 19 (A53-B/A2.26) Mouse Monoclonal Antibody	760-4281	FDA UDI	Class I	Active
Vimentin (EP21) Rabbit Monoclonal Primary Antibody	347R-25	FDA UDI	Class I	Active
Parathyroid Hormone (PTH) (MRQ-31) Mouse Monoclonal Antibody	310M-26	FDA UDI	Class I	Active
Desmoglein 3 (5G11) Mouse Monoclonal Primary Antibody	760-5060	FDA UDI	Class I	Active
CD3 Rabbit Polyclonal Antibody	103A-74	FDA UDI	Class I	Active
Heat Shock Protein 70 (EP377) Rabbit Monoclonal Primary Antibody	460R-14	FDA UDI	Class I	Active
Cytokeratin 5 & 6 (D5 & 16B4) Mouse Monoclonal Antibody	356M-10	FDA UDI	Class I	Active
C4d (SP91) Rabbit Monoclonal Antibody	404R-16	FDA UDI	Class I	Active
IgG4 (EP138) Rabbit Monoclonal Primary Antibody	367R-15	FDA UDI	Class I	Active
CD117, c-kit (YR145) Rabbit Monoclonal Primary Antibody	117R-14-ASR	FDA UDI	Class I	Active
Neurofilament (2F11) Mouse Monoclonal Antibody	302M-14	FDA UDI	Class I	Active
Renal Cell Carcinoma (PN-15) Mouse Monoclonal Antibody	329M-90	FDA UDI	Class I	Active
CD163 (MRQ-26) Mouse Monoclonal Antibody	163M-18	FDA UDI	Class I	Active
SOX-2 (EP103) Rabbit Monoclonal Primary Antibody	371R-26	FDA UDI	Class I	Active
TAG-72 (B72.3) Mouse Monoclonal Antibody	337M-84	FDA UDI	Class I	Active
CD19 (EP169) Rabbit Monoclonal Primary Antibody	119R-14	FDA UDI	Class I	Active
Glucagon Rabbit Polyclonal Antibody	760-2644	FDA UDI	Class I	Active
Heat Shock Protein 70 (EP377) Rabbit Monoclonal Primary Antibody	460R-17	FDA UDI	Class I	Active
PSA (ER-PR8) Mouse Monoclonal Antibody	324M-18	FDA UDI	Class I	Active
LH Rabbit Polyclonal Antibody	209A-18	FDA UDI	Class I	Active
CD1a (EP3622) Rabbit Monoclonal Primary Antibody	101R-18	FDA UDI	Class I	Active
CEA Rabbit Polyclonal Antibody	236A-16	FDA UDI	Class I	Active
Uroplakin II (MRQ-71) Rabbit Monoclonal Antibody	491R-98	FDA UDI	Class I	Active
CD19 (EP169) Rabbit Monoclonal Primary Antibody	119R-18	FDA UDI	Class I	Active
CD8 (SP16) Rabbit Monoclonal Antibody	108R-18	FDA UDI	Class I	Active
Ksp-cadherin (MRQ-33) Mouse Monoclonal Antibody	276M-96	FDA UDI	Class I	Active
FSH (EP257) Rabbit Monoclonal Primary Antibody	207R-17	FDA UDI	Class I	Active
CD19 (MRQ-36) Mouse Monoclonal Antibody	119M-14	FDA UDI	Class I	Active
SV40 (MRQ-4) Mouse Monoclonal Antibody	351M-15-ASR	FDA UDI	Class I	Active
Myeloperoxidase Rabbit Polyclonal Antibody	289A-74	FDA UDI	Class I	Active
Neurofilament (EP79) Rabbit Monoclonal Primary Antibody	302R-18	FDA UDI	Class I	Active
Tyrosinase (T311) Mouse Monoclonal Antibody	344M-94	FDA UDI	Class I	Active
CD20 (L26) Mouse Monoclonal Antibody	120M-86	FDA UDI	Class I	Active
COX-2 (SP21) Rabbit Monoclonal Antibody	760-4254	FDA UDI	Class I	Active
IgM Rabbit Polyclonal Antibody	270A-17	FDA UDI	Class I	Active
Nanog (EP225) Rabbit Monoclonal Primary Antibody	443R-15	FDA UDI	Class I	Active
EGFR (SP84) Rabbit Monoclonal Antibody	414R-15-ASR	FDA UDI	Class I	Active
Androgen Receptor (EP120) Rabbit Monoclonal Primary Antibody	200R-24	FDA UDI	Class I	Active
CD138 (EP201) Rabbit Monoclonal Primary Antibody	138R-25	FDA UDI	Class I	Active
CD19 (EP169) Rabbit Monoclonal Primary Antibody	119R-16	FDA UDI	Class I	Active
Toxoplasma gondii Rabbit Polyclonal Antibody	220A-16-ASR	FDA UDI	Class I	Active
MAGEC2 (EP405) Rabbit Monoclonal Primary Antibody	477R-15	FDA UDI	Class I	Unknown
Villin (EP163) Rabbit Monoclonal Primary Antibody	346R-18	FDA UDI	Class I	Active
Estrogen Receptor (EP1) Rabbit Monoclonal Primary Antibody	249R-20-ASR	FDA UDI	Class I	Active
Langerin (12D6) Mouse Monoclonal Antibody	392M-17	FDA UDI	Class I	Active
Smoothelin (R4A) Mouse Monoclonal Antibody	377M-15	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.