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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 34 of 44

Device	Model / Reference	Registries	Class	Status
Nestin (10C2) Mouse Monoclonal Antibody	388M-18	FDA UDI	Class I	Active
MUM1 (MRQ-8) Mouse Monoclonal Antibody	358M-18	FDA UDI	Class I	Active
Synaptophysin Rabbit Polyclonal Antibody	336A-76	FDA UDI	Class I	Active
Carbonic Anhydrase IX (CA IX) (EP161) Rabbit Monoclonal Primary Antibody	379R-15	FDA UDI	Class I	Active
T-bet (MRQ-46) Rabbit Monoclonal Antibody	368R-75	FDA UDI	Class I	Active
PD-1 (NAT105) Mouse Monoclonal Antibody	315M-96	EUDAMEDFDA UDI	Class I	Active
Human Placental Lactogen (hPL) Rabbit Polyclonal Antibody	266A-17	FDA UDI	Class I	Active
Ksp-cadherin (MRQ-33) Mouse Monoclonal Antibody	276M-97	FDA UDI	Class I	Active
ROS1 (MRQ-68) Rabbit Monoclonal Antibody	469R-96-ASR	FDA UDI	Class I	Unknown
Myeloperoxidase (SP72) Rabbit Monoclonal Antibody	289R-18	FDA UDI	Class I	Active
CD38 (SP149) Rabbit Monoclonal Primary Antibody	760-4785	EUDAMEDFDA UDI	Class I	Active
PMS2 (EPR3947) Rabbit Monoclonal Primary Antibody	288R-10-ASR	FDA UDI	Class I	Active
Glucagon (EP74) Rabbit Monoclonal Primary Antibody	259R-16	FDA UDI	Class I	Active
CD1a (EP3622) Rabbit Monoclonal Antibody	760-4525	EUDAMEDFDA UDI	Class I	Active
Peripherin (8G2) Mouse Monoclonal Antibody	476M-17	FDA UDI	Class I	Active
PLAP (SP15) Rabbit Monoclonal Antibody	321R-14	FDA UDI	Class I	Active
NSE (MRQ-55) Mouse Monoclonal Antibody	306M-28	FDA UDI	Class I	Active
CD43 (MT1) Mouse Monoclonal Antibody	143M-17	FDA UDI	Class I	Active
Cytokeratin (34betaE12) Mouse Monoclonal Antibody	334M-84	FDA UDI	Class I	Active
GCDFP-15 (EP1582Y) Rabbit Monoclonal Primary Antibody	257R-15	FDA UDI	Class I	Active
Stathmin (SP49) Rabbit Monoclonal Antibody	394R-15	FDA UDI	Class I	Active
BOB.1 (SP92) Rabbit Monoclonal Antibody	294R-18	FDA UDI	Class I	Active
PSAP (PASE/4LJ) Mouse Monoclonal Antibody	326M-18	FDA UDI	Class I	Active
SALL4 (6E3) Mouse Monoclonal Antibody	385M-15	EUDAMEDFDA UDI	Class I	Active
Adenovirus (2/6 & 20/11) Mouse Monoclonal Antibody	760-4870	FDA UDI	Class I	Unknown
CD23 (1B12) Mouse Monoclonal Antibody	123M-18	FDA UDI	Class I	Active
S-100 (4C4.9) Mouse Monoclonal Antibody	330M-14	EUDAMEDFDA UDI	Class I	Active
H3.3 G34W (RM263) Rabbit Monoclonal Antibody	493R-16	FDA UDI	Class I	Active
IgA Rabbit Polyclonal Antibody	267A-18	FDA UDI	Class I	Active
CD7 (MRQ-56) Mouse Monoclonal Antibody	107M-27	FDA UDI	Class I	Active
Estrogen Receptor (EP1) Rabbit Monoclonal Primary Antibody	249R-28-ASR	FDA UDI	Class I	Active
Lambda (Lamb14) Mouse Monoclonal Antibody	277M-98	FDA UDI	Class I	Active
MyoD1 (EP212) Rabbit Monoclonal Primary Antibody	760-4900	EUDAMEDFDA UDI	Class I	Active
Epstein-Barr Virus (MRQ-47) Rabbit Monoclonal Antibody	245R-14-ASR	FDA UDI	Class I	Active
CD23 (EP75) Rabbit Monoclonal Primary Antibody	123R-25	FDA UDI	Class I	Active
Spectrin (RBC2/3D5) Mouse Monoclonal Antibody	333M-17	FDA UDI	Class I	Active
Treponema pallidum Rabbit Polyclonal Antibody	397A-17-ASR	FDA UDI	Class I	Active
Cytokeratin (CAM 5.2) Mouse Monoclonal Antibody	452M-94	EUDAMEDFDA UDI	Class I	Active
p53 (DO7) Mouse Monoclonal Antibody	453M-94	FDA UDI	Class I	Active
GLUT3 Rabbit Polyclonal Antibody	413A-17	FDA UDI	Class I	Active
CD61 (EP65) Rabbit Monoclonal Primary Antibody	161R-14	FDA UDI	Class I	Active
Lambda (EP172) Rabbit Monoclonal Primary Antibody	277R-17	FDA UDI	Class I	Active
Ep-CAM/Epithelial Specific Antigen (MOC-31) Mouse Monoclonal Antibody	248M-18	EUDAMEDFDA UDI	Class I	Active
EMA (E29) Mouse Monoclonal Antibody	247M-98	FDA UDI	Class I	Active
Villin (CWWB1) Mouse Monoclonal Antibody	760-4277	FDA UDI	Class I	Active
Perforin (MRQ-23) Mouse Monoclonal Antibody	316M-15	FDA UDI	Class I	Active
Caldesmon (E89) Rabbit Monoclonal Primary Antibody	230R-14	FDA UDI	Class I	Active
HHV-8 (13B10) Mouse Monoclonal Antibody	265M-16-ASR	EUDAMEDFDA UDI	Class I	Active
MUC4 (8G7) Mouse Monoclonal Antibody	406M-14	EUDAMEDFDA UDI	Class I	Active
CD15 (MMA) Mouse Monoclonal Antibody	115M-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.