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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 23 of 44

Device	Model / Reference	Registries	Class	Status
CD35 (EP197) Rabbit Monoclonal Primary Antibody	135R-18	FDA UDI	Class I	Active
Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody	251M-14	FDA UDI	Class I	Active
INSM1 (MRQ-70) Rabbit Monoclonal Antibody	475R-98	FDA UDI	Class I	Unknown
MDM2 (IF2) Mouse Monoclonal Antibody	479M-96	FDA UDI	Class I	Unknown
CD23 (1B12) Mouse Monoclonal Antibody	123M-16	FDA UDI	Class I	Active
Granzyme B Rabbit Polyclonal Antibody	262A-18	FDA UDI	Class I	Active
Ksp-cadherin (MRQ-33) Mouse Monoclonal Antibody	276M-95	FDA UDI	Class I	Active
Ki-67 (MRQ-64) Rabbit Monoclonal Antibody	275R-38	FDA UDI	Class I	Unknown
Helicobacter pylori Rabbit Polyclonal Antibody	215A-77-ASR	FDA UDI	Class I	Active
Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary Antibody	203R-18	FDA UDI	Class I	Active
Uroplakin II (MRQ-71) Rabbit Monoclonal Antibody	491R-97	FDA UDI	Class I	Active
Alpha-Fetoprotein Rabbit Polyclonal Antibody	760-2603	FDA UDI	Class I	Active
Cathepsin K (3F9) Mouse Monoclonal Antibody	402M-18	FDA UDI	Class I	Active
FoxP1 (SP133) Rabbit Monoclonal Antibody	350R-18	FDA UDI	Class I	Active
Epstein-Barr Virus (CS1-4) Mouse Monoclonal Antibody	245M-17-ASR	FDA UDI	Class I	Active
Myogenin (F5D) Mouse Monoclonal Antibody	296M-14	FDA UDI	Class I	Active
MUC1 (MRQ-17) Mouse Monoclonal Antibody	290M-18	FDA UDI	Class I	Active
Cytokeratin (CAM 5.2) Mouse Monoclonal Antibody	452M-95	FDA UDI	Class I	Active
T-bet (MRQ-46) Rabbit Monoclonal Antibody	368R-76	FDA UDI	Class I	Active
Caldesmon (E89) Rabbit Monoclonal Primary Antibody	230R-15	FDA UDI	Class I	Active
PAX-2 (EP235) Rabbit Monoclonal Primary Antibody	311R-17	FDA UDI	Class I	Active
Tryptase (G3) Mouse Monoclonal Antibody	342M-16	FDA UDI	Class I	Active
Herpes Simplex Virus II Rabbit Polyclonal Antibody	362A-77-ASR	FDA UDI	Class I	Active
Arginase-1 (EP261) Rabbit Monoclonal Primary Antibody	380R-25	FDA UDI	Class I	Active
Islet-1 (EP283) Rabbit Monoclonal Primary Antibody	431R-15	FDA UDI	Class I	Active
Cadherin-17 (SP183) Rabbit Monoclonal Antibody	378R-17	FDA UDI	Class I	Active
PAX-5 (24) Mouse Monoclonal Antibody	312M-17	FDA UDI	Class I	Active
Hepatitis B Virus Surface Antigen (S1-210) Mouse Monoclonal Antibody	217M-16-ASR	FDA UDI	Class I	Active
GLUT1 Rabbit Polyclonal Antibody	355A-17	FDA UDI	Class I	Active
CD14 (EPR3653) Rabbit Monoclonal Primary Antibody	114R-16	FDA UDI	Class I	Active
Herpes Simplex Virus I Rabbit Polyclonal Antibody	361A-18-ASR	FDA UDI	Class I	Active
Nerve Growth Factor Receptor (NGFR) (MRQ-21) Mouse Monoclonal Antibody	304M-17	FDA UDI	Class I	Active
CD19 (MRQ-36) Mouse Monoclonal Antibody	119M-16	FDA UDI	Class I	Active
TdT (EP266) Rabbit Monoclonal Primary Antibody	338R-24	FDA UDI	Class I	Active
Cytokeratin (CAM 5.2) Mouse Monoclonal Antibody	452M-98	FDA UDI	Class I	Active
Pit-1 (ZM385) Mouse Monoclonal Antibody	496M-14	FDA UDI	Class I	Active
TTF-1 (8G7G3/1) Mouse Monoclonal Antibody	343M-97	EUDAMEDFDA UDI	Class I	Active
IgG4 (EP138) Rabbit Monoclonal Primary Antibody	367R-16	FDA UDI	Class I	Active
PMS2 (MRQ-28) Mouse Monoclonal Antibody	288M-14-ASR	FDA UDI	Class I	Active
TROP2 (EP431) Rabbit Monoclonal Primary Antibody	465R-18	FDA UDI	Class I	Active
Phosphohistone H3 (PHH3) Rabbit Polyclonal Antibody	369A-10	FDA UDI	Class I	Active
Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody	468R-17	FDA UDI	Class I	Unknown
PAX-5 (EP156) Rabbit Monoclonal Primary Antibody	312R-25	FDA UDI	Class I	Active
CD79a (JCB117) Mouse Monoclonal Antibody	179M-94	FDA UDI	Class I	Active
Cytokeratin 19 (A53-B/A2.26) Mouse Monoclonal Antibody	319M-17	FDA UDI	Class I	Active
CD43 (MT1) Mouse Monoclonal Antibody	143M-16	FDA UDI	Class I	Active
Progesterone Receptor (SP42) Rabbit Monoclonal Antibody	323R-37-ASR	FDA UDI	Class I	Active
PSMA (EP192) Rabbit Monoclonal Primary Antibody	327R-15	FDA UDI	Class I	Active
GCDFP-15 (23A3) Mouse Monoclonal Antibody	257M-15	FDA UDI	Class I	Active
CD21 (EP3093) Rabbit Monoclonal Primary Antibody	121R-18	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.