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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 18 of 44

Device	Model / Reference	Registries	Class	Status
TROP2 (EP431) Rabbit Monoclonal Primary Antibody	465R-14	FDA UDI	Class I	Active
Beta-Catenin (14) Mouse Monoclonal Antibody	224M-16	FDA UDI	Class I	Active
GH Rabbit Polyclonal Antibody	208A-75	FDA UDI	Class I	Active
H3 K36M (RM193) Rabbit Monoclonal Antibody	495R-15	FDA UDI	Class I	Active
LIN28 (EP150) Rabbit Monoclonal Primary Antibody	464R-18	FDA UDI	Class I	Active
Inhibin, alpha (R1) Mouse Monoclonal Antibody	760-2834	FDA UDI	Class I	Active
IgM Rabbit Polyclonal Antibody	270A-14	FDA UDI	Class I	Active
Her2/Neu (SP3) Rabbit Monoclonal Antibody	237R-18-ASR	FDA UDI	Class I	Active
Herpes Simplex Virus II Rabbit Polyclonal Antibody	362A-78-ASR	FDA UDI	Class I	Active
HMB-45 + Mart-1 (Melan A) (A103) + Tyrosinase (T311) Mouse Monoclonal Antibody	904H-00	FDA UDI	Class I	Active
SOX-2 (SP76) Rabbit Monoclonal Antibody	371R-15	FDA UDI	Class I	Active
CD13 (EP117) Rabbit Monoclonal Primary Antibody	113R-25	FDA UDI	Class I	Active
Phosphohistone H3 (PHH3) Rabbit Polyclonal Antibody	369A-16	FDA UDI	Class I	Active
Pneumocystis jiroveci (carinii) (3F6) Mouse Monoclonal Antibody	219M-18-ASR	FDA UDI	Class I	Active
IgM Rabbit Polyclonal Antibody	270A-15	FDA UDI	Class I	Active
BCL2 (124) Mouse Monoclonal Antibody	226M-94	FDA UDI	Class I	Active
ROS1 (MRQ-68) Rabbit Monoclonal Antibody	469R-96	FDA UDI	Class I	Unknown
CD99 (EPR3097Y) Rabbit Monoclonal Primary Antibody	199R-18	FDA UDI	Class I	Active
Herpes Simplex Virus I (10A3) Mouse Monoclonal Antibody	361M-17-ASR	FDA UDI	Class I	Active
MLH1 (M1) Mouse Monoclonal Antibody	285M-24-ASR	FDA UDI	Class I	Active
MART-1 (Melan A) (M2-7C10) Mouse Monoclonal Antibody	281M-94	FDA UDI	Class I	Active
Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody	468R-15	FDA UDI	Class I	Unknown
EGFR (SP84) Rabbit Monoclonal Antibody	414R-16-ASR	FDA UDI	Class I	Active
PLAP (SP15) Rabbit Monoclonal Antibody	321R-15	FDA UDI	Class I	Active
CD68 (Kp-1) Mouse Monoclonal Antibody	168M-97	FDA UDI	Class I	Active
CD14 (EPR3653) Rabbit Monoclonal Primary Antibody	114R-15	FDA UDI	Class I	Active
MSH6 (44) Mouse Monoclonal Antibody	287M-16-ASR	FDA UDI	Class I	Active
GCDFP-15 (EP1582Y) Rabbit Monoclonal Antibody	760-4386	EUDAMEDFDA UDI	Class I	Active
Androgen Receptor (EP120) Rabbit Monoclonal Primary Antibody	200R-27	FDA UDI	Class I	Active
CD34 (QBEnd/10) Mouse Monoclonal Antibody	134M-17	FDA UDI	Class I	Active
PNL2 (PNL2) Mouse Monoclonal Antibody	365M-95	FDA UDI	Class I	Active
BCL2 (124) Mouse Monoclonal Antibody	226M-96	FDA UDI	Class I	Active
CD44 (MRQ-13) Mouse Monoclonal Antibody	144M-95	FDA UDI	Class I	Active
Claudin 1 Rabbit Polyclonal Antibody	359A-15	FDA UDI	Class I	Active
GH Rabbit Polyclonal Antibody	208A-74	FDA UDI	Class I	Active
Fascin (55k-2) Mouse Monoclonal Antibody	252M-17	FDA UDI	Class I	Active
Granzyme B Rabbit Polyclonal Antibody	262A-17	FDA UDI	Class I	Active
Prostein (EP381) Rabbit Monoclonal Primary Antibody	450R-15	FDA UDI	Class I	Active
Villin (EP163) Rabbit Monoclonal Primary Antibody	346R-14	FDA UDI	Class I	Active
S100P (16/f5) Mouse Monoclonal Antibody	376M-95	FDA UDI	Class I	Active
CD44 (MRQ-13) Mouse Monoclonal Antibody	144M-98	FDA UDI	Class I	Active
Cytokeratin 5 (EP1601Y) + Cytokeratin 14 (LL002) Mouse and Rabbit Monoclonal Ant	905H-08	FDA UDI	Class I	Active
BG8, LewisY (F3) Mouse Monoclonal Antibody	228M-14	FDA UDI	Class I	Active
CD11c (5D11) Mouse Monoclonal Antibody	111M-16	FDA UDI	Class I	Active
PD-L1 (ZR3) Rabbit Monoclonal Antibody	438R-24-ASR	FDA UDI	Class I	Active
Toxoplasma gondii Rabbit Polyclonal Antibody	220A-15-ASR	FDA UDI	Class I	Active
Arginase-1 (EP261) Rabbit Monoclonal Primary Antibody	380R-24	FDA UDI	Class I	Active
CD45RO (UCHL-1) Mouse Monoclonal Antibody	147M-97	FDA UDI	Class I	Active
FLI-1 (MRQ-1) Mouse Monoclonal Antibody	254M-18	FDA UDI	Class I	Active
MSH2 (G219-1129) Mouse Monoclonal Antibody	286M-16-ASR	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.