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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 21 of 44

Device	Model / Reference	Registries	Class	Status
FLI-1 (MRQ-1) Mouse Monoclonal Antibody	254M-15	FDA UDI	Class I	Active
Stathmin (SP49) Rabbit Monoclonal Antibody	394R-14	FDA UDI	Class I	Active
Glucagon Rabbit Polyclonal Antibody	259A-18	FDA UDI	Class I	Active
CA-125 (OC125) Mouse Monoclonal Antibody	325M-14	FDA UDI	Class I	Active
CD123 (6H6) Mouse Monoclonal Antibody	198M-16	FDA UDI	Class I	Active
Inhibin, alpha (MRQ-63) Rabbit Monoclonal Antibody	271R-26	FDA UDI	Class I	Active
STAT6 (EP325) Rabbit Monoclonal Primary Antibody	426R-17	EUDAMEDFDA UDI	Class I	Active
EMA (E29) Mouse Monoclonal Antibody	247M-95	FDA UDI	Class I	Active
Oct-2 (MRQ-2) Mouse Monoclonal Antibody	760-4447	FDA UDI	Class I	Active
Calponin (CALP) Mouse Monoclonal Antibody	231M-17	FDA UDI	Class I	Active
Hemoglobin A (EPR3608) Rabbit Monoclonal Primary Antibody	360R-17	FDA UDI	Class I	Active
CMV (DDG9/CCH2) Mouse Monoclonal Antibody	213M-15-ASR	FDA UDI	Class I	Active
Spectrin (RBC2/3D5) Mouse Monoclonal Antibody	333M-18	FDA UDI	Class I	Active
ALK Protein (ALK-1) Mouse Monoclonal Antibody	204M-15	FDA UDI	Class I	Active
Toxoplasma gondii Rabbit Polyclonal Antibody	220A-14-ASR	FDA UDI	Class I	Active
Mesothelin (EP140) Rabbit Monoclonal Primary Antibody	439R-16	FDA UDI	Class I	Active
Herpes Simplex Virus I (10A3) Mouse Monoclonal Antibody	361M-15-ASR	FDA UDI	Class I	Active
Desmin (D33) Mouse Monoclonal Antibody	243M-17	FDA UDI	Class I	Active
NUTM1 (C52B1) Rabbit Monoclonal Antibody	494R-15	FDA UDI	Class I	Active
PLAP (NB10) Mouse Monoclonal Antibody	321M-15	FDA UDI	Class I	Active
Vimentin (V9) Mouse Monoclonal Antibody	347M-15	FDA UDI	Class I	Active
p63 (EP174) Rabbit Monoclonal Primary Antibody	482R-10	FDA UDI	Class I	Active
Synaptophysin Rabbit Polyclonal Antibody	336A-70	FDA UDI	Class I	Active
IgA (EP170) Rabbit Monoclonal Primary Antibody	267R-17	FDA UDI	Class I	Active
Human Placental Lactogen (hPL) Rabbit Polyclonal Antibody	266A-18	FDA UDI	Class I	Active
CD4 (SP35) Rabbit Monoclonal Antibody	104R-15	EUDAMEDFDA UDI	Class I	Active
Cytokeratin (CAM 5.2) Mouse Monoclonal Antibody	452M-90	FDA UDI	Class I	Active
Treponema pallidum Rabbit Polyclonal Antibody	397A-17	FDA UDI	Class I	Unknown
CD138 (EP201) Rabbit Monoclonal Primary Antibody	138R-27	FDA UDI	Class I	Active
CD34 (EP88) Rabbit Monoclonal Primary Antibody	134R-16	FDA UDI	Class I	Active
Villin (EP163) Rabbit Monoclonal Primary Antibody	346R-16	FDA UDI	Class I	Active
Kappa (L1C1) Mouse Monoclonal Antibody	274M-96	FDA UDI	Class I	Active
h-Caldesmon (hHCD) Mouse Monoclonal Antibody	451M-14	FDA UDI	Class I	Active
Beta-Catenin (14) Mouse Monoclonal Antibody	224M-17	FDA UDI	Class I	Active
EZH2 (11) Mouse Monoclonal Antibody	415M-14	FDA UDI	Class I	Active
Somatostatin (EP130) Rabbit Monoclonal Primary Antibody	332R-15	FDA UDI	Class I	Active
SOX-11 (MRQ-58) Mouse Monoclonal Primary Antibody	760-4868	FDA UDI	Class I	Active
FOXA1 (2F83) Mouse Monoclonal Antibody	405M-18	FDA UDI	Class I	Active
CD117, c-kit (YR145) Rabbit Monoclonal Primary Antibody	117R-15-ASR	FDA UDI	Class I	Active
PD-1 (NAT105) Mouse Monoclonal Antibody	315M-97	FDA UDI	Class I	Active
CD33 (PWS44) Mouse Monoclonal Antibody	133M-17	FDA UDI	Class I	Active
CD56 (123C3.D5) Mouse Monoclonal Antibody	156M-85	FDA UDI	Class I	Active
TFE3 (MRQ-37) Rabbit Monoclonal Antibody	354R-16	FDA UDI	Class I	Active
Chromogranin A (LK2H10) Mouse Monoclonal Antibody	238M-95	FDA UDI	Class I	Active
Actin, Muscle Specific (HHF35) Mouse Monoclonal Antibody	201M-90	FDA UDI	Class I	Active
Glial Fibrillary Acidic Protein (GFAP) (SP78) Rabbit Monoclonal Antibody	258R-27	FDA UDI	Class I	Active
FOXP1 (EP137) Rabbit Monoclonal Primary Antibody	350R-26	FDA UDI	Class I	Active
MUC6 (MRQ-20) Mouse Monoclonal Antibody	293M-95	FDA UDI	Class I	Active
SALL4 (EP299) Rabbit Monoclonal Primary Antibody	385R-17	FDA UDI	Class I	Active
C4d (SP91) Rabbit Monoclonal Antibody	404R-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.