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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 6 of 44

Device	Model / Reference	Registries	Class	Status
FSH Rabbit Polyclonal Antibody	207A-76	FDA UDI	Class I	Active
IgG4 (MRQ-44) Mouse Monoclonal Antibody	367M-14	EUDAMEDFDA UDI	Class I	Active
CA19-9 (121SLE) Mouse Monoclonal Antibody	399M-16	FDA UDI	Class I	Active
Inhibin, alpha (R1) Mouse Monoclonal Antibody	271M-15	FDA UDI	Class I	Active
Varicella Zoster Virus (SG1-1, SG1-SG4, NCP-1 & IE-62) Mouse Monoclonal Antibody	364M-16-ASR	FDA UDI	Class I	Active
CD63 (NKI/C3) Mouse Monoclonal Antibody	263M-15	FDA UDI	Class I	Active
Fascin (55k-2) Mouse Monoclonal Antibody	252M-16	FDA UDI	Class I	Active
Treponema pallidum Rabbit Polyclonal Antibody	397A-15	FDA UDI	Class I	Unknown
PHOX2B Rabbit Polyclonal Antibody	422A-17	FDA UDI	Class I	Active
Pit-1 (ZM385) Mouse Monoclonal Antibody	496M-16	FDA UDI	Class I	Active
Treponema pallidum Rabbit Polyclonal Antibody	397A-18	FDA UDI	Class I	Unknown
TROP2 (EP431) Rabbit Monoclonal Primary Antibody	465R-15	FDA UDI	Class I	Active
Estrogen Receptor (EP1) Rabbit Monoclonal Primary Antibody	249R-27-ASR	FDA UDI	Class I	Active
p16INK4A (JC2) Mouse Monoclonal Antibody	416M-16-ASR	FDA UDI	Class I	Active
Treponema pallidum Rabbit Polyclonal Antibody	397A-18-ASR	FDA UDI	Class I	Active
NKX2.2 (EP336) Rabbit Monoclonal Primary Antibody	445R-16	FDA UDI	Class I	Active
CD34 (EP88) Rabbit Monoclonal Primary Antibody	134R-15	FDA UDI	Class I	Active
Cytokeratin 14 (LL002) Mouse Monoclonal Antibody	314M-15	FDA UDI	Class I	Active
Myosin, Smooth Muscle (EP166) Rabbit Monoclonal Primary Antibody	298R-18	FDA UDI	Class I	Active
Cytokeratin 14 (LL002) Mouse Monoclonal Antibody	314M-14	FDA UDI	Class I	Active
C4d Rabbit Polyclonal Antibody	404A-16	FDA UDI	Class I	Active
TdT (EP266) Rabbit Monoclonal Primary Antibody	338R-26	FDA UDI	Class I	Active
FOXA1 (2F83) Mouse Monoclonal Antibody	405M-15	FDA UDI	Class I	Active
Hepatocyte Specific Antigen (Hep-Par1) (EP265) Rabbit Monoclonal Primary Antibod	264R-14	FDA UDI	Class I	Active
Langerin (12D6) Mouse Monoclonal Antibody	392M-14	FDA UDI	Class I	Active
CD23 (EP75) Rabbit Monoclonal Primary Antibody	123R-24	FDA UDI	Class I	Active
MAGEC2 (EP405) Rabbit Monoclonal Primary Antibody	477R-14	FDA UDI	Class I	Unknown
C3d Rabbit Polyclonal Antibody	403A-78	FDA UDI	Class I	Active
PAX-5 (SP34) Rabbit Monoclonal Antibody	312R-17	FDA UDI	Class I	Active
MUM1 (MRQ-43) Rabbit Monoclonal Antibody	358R-78	FDA UDI	Class I	Active
TdT (EP266) Rabbit Monoclonal Primary Antibody	338R-28	FDA UDI	Class I	Active
CD7 (EP132) Rabbit Monoclonal Primary Antibody	107R-15	FDA UDI	Class I	Active
PMS2 (MRQ-28) Mouse Monoclonal Antibody	288M-18-ASR	FDA UDI	Class I	Active
ALK Protein (ALK-1) Mouse Monoclonal Antibody	204M-17	FDA UDI	Class I	Active
Smoothelin (R4A) Mouse Monoclonal Antibody	377M-18	FDA UDI	Class I	Active
SV40 (MRQ-4) Mouse Monoclonal Antibody	351M-14-ASR	FDA UDI	Class I	Active
CMV (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Antibody	213M-28-ASR	FDA UDI	Class I	Active
CD4 (EP204) Rabbit Monoclonal Primary Antibody	104R-28	FDA UDI	Class I	Active
ALK Protein (ALK-1) Mouse Monoclonal Antibody	204M-16	FDA UDI	Class I	Active
p53 (SP5) Rabbit Monoclonal Antibody	453R-14	FDA UDI	Class I	Active
GLUT3 Rabbit Polyclonal Antibody	413A-15	FDA UDI	Class I	Active
IgD Rabbit Polyclonal Antibody	268A-14	FDA UDI	Class I	Active
Cytokeratin 5 & 6 (EP24 & EP67) Rabbit Monoclonal Primary Antibody	356R-16	FDA UDI	Class I	Active
Smoothelin (R4A) Mouse Monoclonal Antibody	377M-17	FDA UDI	Class I	Active
HBME-1 (HBME-1) Mouse Monoclonal Antibody	283M-17	FDA UDI	Class I	Active
Lambda (EP172) Rabbit Monoclonal Primary Antibody	277R-14	FDA UDI	Class I	Active
PAX-5 (EP156) Rabbit Monoclonal Primary Antibody	312R-27	FDA UDI	Class I	Active
Myeloperoxidase (SP72) Rabbit Monoclonal Antibody	289R-15	FDA UDI	Class I	Active
MUM1 (MRQ-43) Rabbit Monoclonal Antibody	358R-76	FDA UDI	Class I	Active
T-bet (MRQ-46) Rabbit Monoclonal Antibody	368R-74	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.