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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 7 of 44

Device	Model / Reference	Registries	Class	Status
CD11c (EP157) Rabbit Monoclonal Primary Antibody	111R-14	FDA UDI	Class I	Active
CD21 (EP3093) Rabbit Monoclonal Primary Antibody	121R-16	FDA UDI	Class I	Active
NKX2.2 (EP336) Rabbit Monoclonal Primary Antibody	445R-15	FDA UDI	Class I	Active
Alpha-Fetoprotein Rabbit Polyclonal Antibody	203A-15	FDA UDI	Class I	Active
Myogenin (F5D) Mouse Monoclonal Antibody	296M-18	FDA UDI	Class I	Active
CD5 (4C7) Mouse Monoclonal Antibody	205M-14	FDA UDI	Class I	Active
IgM Rabbit Polyclonal Antibody	760-2654	FDA UDI	Class I	Active
Villin (EP163) Rabbit Monoclonal Primary Antibody	346R-17	FDA UDI	Class I	Active
Tryptase (G3) Mouse Monoclonal Antibody	342M-15	FDA UDI	Class I	Active
MUC1 (MRQ-17) Mouse Monoclonal Antibody	290M-17	FDA UDI	Class I	Active
Myoglobin Rabbit Polyclonal Antibody	297A-75	FDA UDI	Class I	Active
Lysozyme Rabbit Polyclonal Antibody	278A-17	FDA UDI	Class I	Active
CMV (DDG9/CCH2) Mouse Monoclonal Antibody	213M-18-ASR	FDA UDI	Class I	Active
Cytokeratin 5 & 6 (D5/16B4) + TTF-1 (8G7G3/1) Mouse Monoclonal Antibody	902H-07	FDA UDI	Class I	Active
PHOX2B Rabbit Polyclonal Antibody	422A-14	FDA UDI	Class I	Active
Her2/Neu (SP3) Rabbit Monoclonal Antibody	237R-16-ASR	FDA UDI	Class I	Active
Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody	251M-18	FDA UDI	Class I	Active
TSH (EP254) Rabbit Monoclonal Primary Antibody	211R-16	FDA UDI	Class I	Active
Actin, Muscle Specific (HHF35) Mouse Monoclonal Antibody	201M-95	FDA UDI	Class I	Active
Olig2 (211F1.1) Mouse Monoclonal Antibody	387M-16	FDA UDI	Class I	Active
CD23 (1B12) Mouse Monoclonal Antibody	123M-17	FDA UDI	Class I	Active
INI-1 (MRQ-27) Mouse Monoclonal Antibody	272M-16	FDA UDI	Class I	Active
Cytokeratin, LMW (AE1) Mouse Monoclonal Antibody	301M-15	FDA UDI	Class I	Active
H3.3 G34W (RM263) Rabbit Monoclonal Antibody	493R-17	FDA UDI	Class I	Active
FSH Rabbit Polyclonal Antibody	207A-77	FDA UDI	Class I	Active
Somatostatin Receptor 2A (EP149) Rabbit Monoclonal Primary Antibody	486R-15	FDA UDI	Class I	Active
p57/Kip2 (Kp10) Mouse Monoclonal Antibody	457M-95	FDA UDI	Class I	Active
CD25 (4C9) Mouse Monoclonal Antibody	125M-18	FDA UDI	Class I	Active
IgD Rabbit Polyclonal Antibody	268A-15	FDA UDI	Class I	Active
Cytokeratin 5 & 6 (EP24 & EP67) Rabbit Monoclonal Primary Antibody	356R-17	FDA UDI	Class I	Active
Olig2 (211F1.1) Mouse Monoclonal Antibody	387M-17	FDA UDI	Class I	Active
IgG4 (MRQ-44) Mouse Monoclonal Antibody	367M-16	EUDAMEDFDA UDI	Class I	Active
TdT Rabbit Polyclonal Antibody	338A-78	FDA UDI	Class I	Active
Glutamine Synthetase (GS-6) Mouse Monoclonal Antibody	389M-17	FDA UDI	Class I	Active
Lambda (Lamb14) Mouse Monoclonal Antibody	277M-97	FDA UDI	Class I	Active
CD11c (5D11) Mouse Monoclonal Antibody	111M-18	FDA UDI	Class I	Active
PAX-8 (SP348) Rabbit Monoclonal Antibody	363R-36	FDA UDI	Class I	Active
Thyroglobulin (MRQ-41) Mouse Monoclonal Antibody	340M-98	FDA UDI	Class I	Active
PAX-5 (24) Mouse Monoclonal Antibody	312M-15	FDA UDI	Class I	Active
PD-L1 (ZR3) Rabbit Monoclonal Antibody	438R-26-ASR	FDA UDI	Class I	Active
p16INK4A (JC2) Mouse Monoclonal Antibody	416M-17-ASR	FDA UDI	Class I	Active
IgD Rabbit Polyclonal Antibody	268A-18	FDA UDI	Class I	Active
Myeloperoxidase Rabbit Polyclonal Antibody	289A-78	FDA UDI	Class I	Active
Desmin (EP15) Rabbit Monoclonal Primary Antibody	243R-16	FDA UDI	Class I	Active
PAX-8 (SP348) Rabbit Monoclonal Antibody	363R-34	FDA UDI	Class I	Active
Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody	340M-14	FDA UDI	Class I	Active
TCL1 (MRQ-7) Mouse Monoclonal Antibody	357M-14	FDA UDI	Class I	Active
CD63 (NKI/C3) Mouse Monoclonal Antibody	760-4379	FDA UDI	Class I	Active
p63 (EP174) Rabbit Monoclonal Primary Antibody	482R-15	FDA UDI	Class I	Active
Mammaglobin (31A5) Rabbit Monoclonal Antibody	280R-16	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.