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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 14 of 44

Device	Model / Reference	Registries	Class	Status
ROS1 (MRQ-68) Rabbit Monoclonal Antibody	469R-95	FDA UDI	Class I	Unknown
SOX-2 (EP103) Rabbit Monoclonal Primary Antibody	371R-27	FDA UDI	Class I	Active
Calponin (CALP) Mouse Monoclonal Antibody	231M-16	FDA UDI	Class I	Active
TLE1 (1F5) Mouse Monoclonal Antibody	401M-14	FDA UDI	Class I	Active
CD56 (123C3.D5) Mouse Monoclonal Antibody	156M-84	FDA UDI	Class I	Active
FSH Rabbit Polyclonal Antibody	207A-75	FDA UDI	Class I	Active
Calcitonin (SP17) Rabbit Monoclonal Antibody	229R-14	FDA UDI	Class I	Active
p27/Kip1 (SX53G8) Mouse Monoclonal Antibody	760-4268	FDA UDI	Class I	Active
Caveolin-1 (SP43) Rabbit Monoclonal Primary Antibody	760-4951	FDA UDI	Class I	Active
CD19 (MRQ-36) Mouse Monoclonal Antibody	119M-17	FDA UDI	Class I	Active
CD103 (EP206) Rabbit Monoclonal Primary Antibody	437R-15	FDA UDI	Class I	Active
Mesothelial Cell (HBME-1) Mouse Monoclonal Antibody	760-4445	EUDAMEDFDA UDI	Class I	Active
Cytokeratin 14 (LL002) Mouse Monoclonal Antibody	314M-18	FDA UDI	Class I	Active
CD15 (MMA) Mouse Monoclonal Antibody	115M-16	FDA UDI	Class I	Active
Mesothelin (EP140) Rabbit Monoclonal Primary Antibody	439R-18	FDA UDI	Class I	Active
Vimentin (V9) Mouse Monoclonal Antibody	347M-16	FDA UDI	Class I	Active
PD-L1 (28-8) Rabbit Monoclonal Primary Antibody	438R-17-ASR	FDA UDI	Class I	Active
Annexin A1 (MRQ-3) Mouse Monoclonal Antibody	221M-16	FDA UDI	Class I	Active
CITED1 (5H6) Mouse Monoclonal Antibody	424M-16	FDA UDI	Class I	Active
Myeloperoxidase (EP151) Rabbit Monoclonal Primary Antibody	289R-25	FDA UDI	Class I	Active
INI-1 (MRQ-27) Mouse Monoclonal Antibody	272M-17	FDA UDI	Class I	Active
PLAP (SP15) Rabbit Monoclonal Antibody	321R-16	FDA UDI	Class I	Active
PSAP (PASE/4LJ) Mouse Monoclonal Antibody	326M-15	FDA UDI	Class I	Active
Calretinin (SP13) Rabbit Monoclonal Antibody	232R-17	FDA UDI	Class I	Active
NUTM1 (C52B1) Rabbit Monoclonal Antibody	494R-17	FDA UDI	Class I	Active
Myeloperoxidase (SP72) Rabbit Monoclonal Antibody	289R-17	FDA UDI	Class I	Active
MSH2 (G219-1129) Mouse Monoclonal Antibody	286M-15-ASR	FDA UDI	Class I	Active
CD25 (4C9) Mouse Monoclonal Antibody	125M-17	FDA UDI	Class I	Active
PD-L1 (28-8) Rabbit Monoclonal Primary Antibody	438R-14-ASR	FDA UDI	Class I	Active
CD13 (EP117) Rabbit Monoclonal Primary Antibody	113R-27	FDA UDI	Class I	Active
IgA Rabbit Polyclonal Antibody	760-2652	FDA UDI	Class I	Active
Kappa (EP171) Rabbit Monoclonal Primary Antibody	274R-18	FDA UDI	Class I	Active
EMA (E29) Mouse Monoclonal Antibody	247M-97	FDA UDI	Class I	Active
Claudin 1 Rabbit Polyclonal Antibody	359A-17	FDA UDI	Class I	Active
MUC6 (MRQ-20) Mouse Monoclonal Antibody	293M-94	FDA UDI	Class I	Active
PD-L1 (ZR3) Rabbit Monoclonal Antibody	438R-25-ASR	FDA UDI	Class I	Active
ERG (EP111) Rabbit Monoclonal Primary Antibody	434R-16	FDA UDI	Class I	Active
Myogenin (EP162) Rabbit Monoclonal Primary Antibody	296R-17	FDA UDI	Class I	Active
Prostein (EP381) Rabbit Monoclonal Primary Antibody	450R-16	FDA UDI	Class I	Active
Cytokeratin 14 (SP53) Rabbit Monoclonal Antibody	314R-16	FDA UDI	Class I	Active
p53 (EP9) Rabbit Monoclonal Primary Antibody	453R-26	FDA UDI	Class I	Active
Desmin (EP15) Rabbit Monoclonal Primary Antibody	243R-15	FDA UDI	Class I	Active
Tyrosine Hydroxylase (LNC1) Mouse Monoclonal Antibody	490M-16	FDA UDI	Class I	Active
C4d Rabbit Polyclonal Antibody	404A-17	FDA UDI	Class I	Active
HHV-8 (13B10) Mouse Monoclonal Antibody	265M-14-ASR	FDA UDI	Class I	Active
CD63 (NKI/C3) Mouse Monoclonal Antibody	263M-16	FDA UDI	Class I	Active
Herpes Simplex Virus II Rabbit Polyclonal Antibody	362A-74-ASR	FDA UDI	Class I	Active
Ki-67 (MRQ-64) Rabbit Monoclonal Antibody	275R-37	FDA UDI	Class I	Unknown
Cytokeratin 17 (EP98) Rabbit Monoclonal Primary Antibody	317R-16	FDA UDI	Class I	Active
LH Rabbit Polyclonal Antibody	209A-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.