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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 25 of 44

Device	Model / Reference	Registries	Class	Status
MSH6 (44) Mouse Monoclonal Antibody	287M-14-ASR	FDA UDI	Class I	Active
MSH2 (G219-1129) Mouse Monoclonal Antibody	286M-10-ASR	FDA UDI	Class I	Active
PAX-8 (SP348) Rabbit Monoclonal Antibody	363R-38	FDA UDI	Class I	Active
Parvovirus B19 (R92F6) Mouse Monoclonal Antibody	218M-15-ASR	FDA UDI	Class I	Active
p53 (EP9) Rabbit Monoclonal Primary Antibody	453R-25	FDA UDI	Class I	Active
Cytokeratin 19 (A53-B/A2.26) Mouse Monoclonal Antibody	319M-18	EUDAMEDFDA UDI	Class I	Active
CD20 (L26) Mouse Monoclonal Antibody	120M-80	FDA UDI	Class I	Active
Adenovirus (20/11 & 2/6) Mouse Monoclonal Antibody	212M-18-ASR	FDA UDI	Class I	Active
p40 (ZR8) Rabbit Monoclonal Antibody	483R-16	FDA UDI	Class I	Active
FOXP1 (EP137) Rabbit Monoclonal Primary Antibody	350R-27	FDA UDI	Class I	Active
MSH6 (44), 0.1ml, concentrate	287M-14	FDA UDI	Class I	Unknown
FoxP1 (SP133) Rabbit Monoclonal Antibody	350R-16	FDA UDI	Class I	Active
Chromogranin A (LK2H10) Mouse Monoclonal Antibody	238M-97	FDA UDI	Class I	Active
TSH (EP254) Rabbit Monoclonal Primary Antibody	211R-18	FDA UDI	Class I	Active
CD15 (MMA) Mouse Monoclonal Antibody	115M-17	FDA UDI	Class I	Active
Progesterone Receptor (SP42) Rabbit Monoclonal Antibody	323R-38-ASR	FDA UDI	Class I	Active
CMV (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Antibody	213M-24-ASR	FDA UDI	Class I	Active
EGFR (SP84) Rabbit Monoclonal Antibody	414R-18-ASR	FDA UDI	Class I	Active
MAGEC2 (EP405) Rabbit Monoclonal Primary Antibody	477R-18	FDA UDI	Class I	Unknown
p53 (SP5) Rabbit Monoclonal Antibody	453R-15	FDA UDI	Class I	Active
p120 Catenin (MRQ-5) Mouse Monoclonal Antibody	420M-18	FDA UDI	Class I	Active
PGP 9.5 Rabbit Polyclonal Antibody	318A-16	FDA UDI	Class I	Active
Napsin A Rabbit Polyclonal Antibody	352A-78	FDA UDI	Class I	Active
BCL2 (SP66) Rabbit Monoclonal Antibody	226R-28	FDA UDI	Class I	Active
Nerve Growth Factor Receptor (NGFR) (MRQ-21) Mouse Monoclonal Antibody	304M-16	FDA UDI	Class I	Active
p53 (SP5) Rabbit Monoclonal Antibody	453R-18	FDA UDI	Class I	Active
PLAP (SP15) Rabbit Monoclonal Antibody	321R-18	FDA UDI	Class I	Active
FSH (EP257) Rabbit Monoclonal Primary Antibody	207R-16	FDA UDI	Class I	Active
PAX-5 (24) Mouse Monoclonal Antibody	312M-14	FDA UDI	Class I	Active
MLH1 (M1) Mouse Monoclonal Antibody	285M-20-ASR	FDA UDI	Class I	Active
Myoglobin Rabbit Polyclonal Antibody	297A-74	FDA UDI	Class I	Active
Langerin (12D6) Mouse Monoclonal Antibody	392M-16	FDA UDI	Class I	Active
Villin (CWWB1) Mouse Monoclonal Antibody	346M-18	FDA UDI	Class I	Active
EMA (E29) Mouse Monoclonal Antibody	247M-90	FDA UDI	Class I	Active
ROS1 (MRQ-68) Rabbit Monoclonal Antibody	469R-97	FDA UDI	Class I	Unknown
CITED1 (5H6) Mouse Monoclonal Antibody	424M-15	FDA UDI	Class I	Active
S100P (16/f5) Mouse Monoclonal Antibody	376M-96	FDA UDI	Class I	Active
BCA-225 (Cu-18) Mouse Monoclonal Antibody	225M-18	FDA UDI	Class I	Active
Caldesmon (E89) Rabbit Monoclonal Primary Antibody	230R-17	FDA UDI	Class I	Active
p53 (EP9) Rabbit Monoclonal Primary Antibody	453R-27	FDA UDI	Class I	Active
PAX-2 (EP235) Rabbit Monoclonal Primary Antibody	311R-14	FDA UDI	Class I	Active
NKX2.2 (EP336) Rabbit Monoclonal Primary Antibody	445R-17	FDA UDI	Class I	Active
PNL2 (PNL2) Mouse Monoclonal Antibody	365M-94	FDA UDI	Class I	Active
Calretinin Rabbit Polyclonal Antibody	232A-77	FDA UDI	Class I	Active
Synaptophysin Rabbit Polyclonal Antibody	336A-78	FDA UDI	Class I	Active
p16INK4A (JC2) Mouse Monoclonal Antibody	416M-10-ASR	FDA UDI	Class I	Active
ROS1 (MRQ-68) Rabbit Monoclonal Antibody	469R-95-ASR	FDA UDI	Class I	Unknown
Kappa (L1C1) Mouse Monoclonal Antibody	274M-94	FDA UDI	Class I	Active
CD31 (EP78) Rabbit Monoclonal Primary Antibody	131R-25	FDA UDI	Class I	Active
H3.3 G34W (RM263) Rabbit Monoclonal Antibody	493R-14	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.