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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 22 of 44

Device	Model / Reference	Registries	Class	Status
Lambda (EP172) Rabbit Monoclonal Primary Antibody	277R-15	FDA UDI	Class I	Active
CD16 (SP175) Rabbit Monoclonal Antibody	116R-15	FDA UDI	Class I	Active
ZAP-70 (2F3.2) Mouse Monoclonal Antibody	760-4278	FDA UDI	Class I	Active
CD3 Rabbit Polyclonal Antibody	103A-78	FDA UDI	Class I	Active
Myosin, Smooth Muscle (EP166) Rabbit Monoclonal Primary Antibody	298R-16	FDA UDI	Class I	Active
ALK Protein (ALK-1) Mouse Monoclonal Antibody	204M-18	FDA UDI	Class I	Active
Kappa (EP171) Rabbit Monoclonal Primary Antibody	274R-14	FDA UDI	Class I	Active
Heat Shock Protein 70 (EP377) Rabbit Monoclonal Primary Antibody	460R-18	FDA UDI	Class I	Active
CMV (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Antibody	213M-27-ASR	FDA UDI	Class I	Active
CD138 (EP201) Rabbit Monoclonal Primary Antibody	138R-26	FDA UDI	Class I	Active
Napsin A (EP205) Rabbit Monoclonal Primary Antibody	352R-18	FDA UDI	Class I	Active
Uroplakin III (AU-1) Mouse Monoclonal Antibody	345M-17	FDA UDI	Class I	Active
EGFR (EP22) Rabbit Monoclonal Primary Antibody	414R-24-ASR	FDA UDI	Class I	Active
Microphthalmia Transcription Factor (MiTF) (C5/D5) Mouse Monoclonal Antibody	284M-96	FDA UDI	Class I	Active
Adipophilin Rabbit Polyclonal Antibody	393A-16	FDA UDI	Class I	Active
Epstein-Barr Virus (MRQ-47) Rabbit Monoclonal Antibody	245R-17-ASR	FDA UDI	Class I	Active
Uroplakin III (SP73) Rabbit Monoclonal Antibody	760-4533	FDA UDI	Class I	Active
Cytokeratin 19 (EP72) Rabbit Monoclonal Primary Antibody	319R-28	FDA UDI	Class I	Active
Uroplakin II (MRQ-71) Rabbit Monoclonal Antibody	491R-95	FDA UDI	Class I	Active
CD25 (4C9) Mouse Monoclonal Antibody	125M-16	FDA UDI	Class I	Active
EGFR (EP22) Rabbit Monoclonal Primary Antibody	414R-26-ASR	FDA UDI	Class I	Active
Epstein-Barr Virus (CS1-4) Mouse Monoclonal Antibody	245M-16-ASR	FDA UDI	Class I	Active
KBA.62 (KBA.62) Mouse Monoclonal Antibody	366M-97	FDA UDI	Class I	Active
PLAP (SP15) Rabbit Monoclonal Antibody	321R-17	FDA UDI	Class I	Active
Calcitonin Rabbit Polyclonal Antibody	760-2611	FDA UDI	Class I	Active
MUC1 (EP85) Rabbit Monoclonal Primary Antibody	290R-14	FDA UDI	Class I	Active
Napsin A (EP205) Rabbit Monoclonal Primary Antibody	352R-17	FDA UDI	Class I	Active
CD25 (4C9) Mouse Monoclonal Antibody	125M-14	FDA UDI	Class I	Active
Hepatitis B Virus Surface Antigen (A10F1) Mouse Monoclonal Antibody	217M-27-ASR	FDA UDI	Class I	Active
Neurofilament (EP79) Rabbit Monoclonal Primary Antibody	302R-17	FDA UDI	Class I	Active
GCDFP-15 (EP1582Y) Rabbit Monoclonal Primary Antibody	257R-18	FDA UDI	Class I	Active
Somatostatin (EP130) Rabbit Monoclonal Primary Antibody	332R-16	FDA UDI	Class I	Active
PMS2 (MRQ-28) Mouse Monoclonal Antibody	288M-15-ASR	FDA UDI	Class I	Active
ROS1 (MRQ-68) Rabbit Monoclonal Antibody	469R-98-ASR	FDA UDI	Class I	Unknown
C3d Rabbit Polyclonal Antibody	403A-77	FDA UDI	Class I	Active
Hepatitis B Virus Surface Antigen (A10F1) Mouse Monoclonal Antibody	217M-25-ASR	FDA UDI	Class I	Active
TSH (EP254) Rabbit Monoclonal Primary Antibody	211R-15	FDA UDI	Class I	Active
EZH2 (11) Mouse Monoclonal Antibody	415M-17	FDA UDI	Class I	Active
HMB-45 + Mart-1 (Melan A) (A103) + Tyrosinase (T311) Mouse Monoclonal Antibody	904H-07	FDA UDI	Class I	Active
MyoD1 (EP212) Rabbit Monoclonal Primary Antibody	386R-17	FDA UDI	Class I	Active
CD68 (Kp-1) Mouse Monoclonal Antibody	168M-96	FDA UDI	Class I	Active
BCL2 (124) Mouse Monoclonal Antibody	226M-95	FDA UDI	Class I	Active
Somatostatin Receptor 2A (EP149) Rabbit Monoclonal Primary Antibody	486R-16	FDA UDI	Class I	Active
S100 beta (EP32) Rabbit Monoclonal Primary Antibody	449R-14	FDA UDI	Class I	Active
Cathepsin K (3F9) Mouse Monoclonal Antibody	402M-16	FDA UDI	Class I	Active
BCL2 (E17) Rabbit Monoclonal Primary Antibody	226R-14	FDA UDI	Class I	Active
BCL6 (EP278) Rabbit Monoclonal Primary Antibody	227R-25	FDA UDI	Class I	Active
Cytokeratin 14 (SP53) Rabbit Monoclonal Antibody	314R-17	FDA UDI	Class I	Active
PHOX2B (EP312) Rabbit Monoclonal Primary Antibody	422R-15	FDA UDI	Class I	Active
Olig2 (EP112) Rabbit Monoclonal Primary Antibody	387R-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.