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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 36 of 44

Device	Model / Reference	Registries	Class	Status
h-Caldesmon (hHCD) Mouse Monoclonal Antibody	451M-17	FDA UDI	Class I	Active
CD5 (SP19) Rabbit Monoclonal Antibody	205R-15	FDA UDI	Class I	Active
Factor XIIIa (EP3372) Rabbit Monoclonal Antibody	760-4441	FDA UDI	Class I	Active
Olig2 (211F1.1) Mouse Monoclonal Antibody	387M-14	FDA UDI	Class I	Active
TLE1 (1F5) Mouse Monoclonal Antibody	401M-15	EUDAMEDFDA UDI	Class I	Active
Myosin, Smooth Muscle (EP166) Rabbit Monoclonal Primary Antibody	298R-14	FDA UDI	Class I	Active
SOX-2 (EP103) Rabbit Monoclonal Primary Antibody	371R-28	FDA UDI	Class I	Active
TAG-72 (B72.3) Mouse Monoclonal Antibody	337M-87	FDA UDI	Class I	Active
SOX-10 Rabbit Polyclonal Antibody	383A-76	FDA UDI	Class I	Active
IgM Rabbit Polyclonal Antibody	270A-16	FDA UDI	Class I	Active
CD4 (EP204) Rabbit Monoclonal Primary Antibody	104R-25	FDA UDI	Class I	Active
CD13 (EP117) Rabbit Monoclonal Primary Antibody	113R-26	FDA UDI	Class I	Active
Cytokeratin 7 (OV-TL 12/30) Mouse Monoclonal Antibody	307M-94	EUDAMEDFDA UDI	Class I	Active
Actin, Muscle Specific (HHF35) Mouse Monoclonal Antibody	201M-96	FDA UDI	Class I	Active
Prostein (EP381) Rabbit Monoclonal Primary Antibody	450R-18	FDA UDI	Class I	Active
Olig2 (EP112) Rabbit Monoclonal Primary Antibody	387R-14	FDA UDI	Class I	Active
CD23 (MRQ-57) Mouse Monoclonal Antibody	123M-25	FDA UDI	Class I	Active
CD56 (123C3.D5) Mouse Monoclonal Antibody	156M-88	FDA UDI	Class I	Active
Olig2 (211F1.1) Mouse Monoclonal Antibody	387M-15	FDA UDI	Class I	Active
TFE3 (MRQ-37) Rabbit Monoclonal Antibody	354R-15	EUDAMEDFDA UDI	Class I	Active
Kappa (L1C1) Mouse Monoclonal Antibody	274M-90	FDA UDI	Class I	Active
Inhibin, alpha (R1) Mouse Monoclonal Antibody	760-2834	FDA UDI	Class I	Unknown
Olig2 (EP112) Rabbit Monoclonal Primary Antibody	387R-15	FDA UDI	Class I	Active
GH (Growth Hormone) Rabbit Polyclonal Antibody	760-2804	FDA UDI	Class I	Active
Glycophorin A (GA-R2) Mouse Monoclonal Antibody	260M-17	FDA UDI	Class I	Active
Neurofilament (2F11) Mouse Monoclonal Antibody	302M-15	FDA UDI	Class I	Active
GCDFP-15 (23A3) Mouse Monoclonal Antibody	257M-18	FDA UDI	Class I	Active
SOX-10 Rabbit Polyclonal Antibody	383A-77	FDA UDI	Class I	Active
CD68 (Kp-1) Mouse Monoclonal Antibody	168M-95	FDA UDI	Class I	Active
CD23 (SP23) Rabbit Monoclonal Antibody	123R-18	FDA UDI	Class I	Active
CD163 (MRQ-26) Mouse Monoclonal Antibody	163M-17	FDA UDI	Class I	Active
CA19-9 (121SLE) Mouse Monoclonal Antibody	760-2609	FDA UDI	Class I	Active
CD57 (NK-1) Mouse Monoclonal Antibody	157M-95	FDA UDI	Class I	Active
Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal Antibodies	280C-18	FDA UDI	Class I	Active
Adipophilin Rabbit Polyclonal Antibody	393A-18	FDA UDI	Class I	Active
KBA.62 (KBA.62) Mouse Monoclonal Antibody	366M-94	FDA UDI	Class I	Active
Calcitonin (SP17) Rabbit Monoclonal Antibody	229R-18	FDA UDI	Class I	Active
H3 K27M (RM192) Rabbit Monoclonal Antibody	492R-17	FDA UDI	Class I	Active
Calretinin Rabbit Polyclonal Antibody	232A-76	FDA UDI	Class I	Active
Annexin A1 (MRQ-3) Mouse Monoclonal Antibody	221M-18	FDA UDI	Class I	Active
Glucagon (EP74) Rabbit Monoclonal Primary Antibody	259R-15	FDA UDI	Class I	Active
Cytokeratin 5 (EP1601Y) Rabbit Monoclonal Primary Antibody	305R-14	FDA UDI	Class I	Active
Glycophorin-A (GA-R2) Mouse Monoclonal Antibody	760-4257	FDA UDI	Class I	Active
Phosphohistone H3 (PHH3) Rabbit Polyclonal Antibody	369A-15	EUDAMEDFDA UDI	Class I	Active
Glial Fibrillary Acidic Protein (GFAP) (SP78) Rabbit Monoclonal Antibody	258R-24	FDA UDI	Class I	Active
Herpes Simplex Virus II (3C5.2) Mouse Monoclonal Antibody	362M-17-ASR	FDA UDI	Class I	Active
Synaptophysin Rabbit Polyclonal Antibody	336A-75	FDA UDI	Class I	Active
Villin (CWWB1) Mouse Monoclonal Antibody	346M-16	FDA UDI	Class I	Active
Cytokeratin 5 (EP1601Y) + Cytokeratin 14 (LL002) Mouse and Rabbit Monoclonal Ant	905H-07	FDA UDI	Class I	Active
Pit-1 (ZM385) Mouse Monoclonal Antibody	496M-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.