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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 12 of 44

Device	Model / Reference	Registries	Class	Status
CD4 (SP35) Rabbit Monoclonal Antibody	104R-17	FDA UDI	Class I	Active
Cadherin-17 (SP183) Rabbit Monoclonal Antibody	378R-16	FDA UDI	Class I	Active
MUC1 (EP85) Rabbit Monoclonal Primary Antibody	290R-17	FDA UDI	Class I	Active
Estrogen Receptor (SP1) Rabbit Monoclonal Antibody	249R-16-ASR	FDA UDI	Class I	Active
Arginase-1 (EP261) Rabbit Monoclonal Primary Antibody	380R-26	FDA UDI	Class I	Active
Desmin (D33) Mouse Monoclonal Antibody	243M-14	FDA UDI	Class I	Active
Progesterone Receptor (SP42) Rabbit Monoclonal Antibody	323R-34-ASR	FDA UDI	Class I	Active
MLH1 (G168-728) Mouse Monoclonal Antibody	285M-10-ASR	FDA UDI	Class I	Active
BOB.1 (SP92) Rabbit Monoclonal Antibody	294R-14	FDA UDI	Class I	Active
Thrombomodulin (1009) Mouse Monoclonal Antibody	339M-16	FDA UDI	Class I	Active
CMV (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Antibody	213M-26-ASR	FDA UDI	Class I	Active
Nestin (10C2) Mouse Monoclonal Antibody	388M-14	FDA UDI	Class I	Active
p40 (ZR8) Rabbit Monoclonal Antibody	483R-15	FDA UDI	Class I	Active
Synaptophysin (EP158) Rabbit Monoclonal Primary Antibody	336R-17	FDA UDI	Class I	Active
Cytokeratin (35betaH11) Mouse Monoclonal Antibody	335M-97	FDA UDI	Class I	Active
PAX-5 (24) Mouse Monoclonal Antibody	312M-16	FDA UDI	Class I	Active
Cytokeratin 17 (EP98) Rabbit Monoclonal Primary Antibody	317R-14	FDA UDI	Class I	Active
Varicella Zoster Virus (SG1-1, SG1-SG4, NCP-1 & IE-62) Mouse Monoclonal Antibody	364M-14-ASR	FDA UDI	Class I	Active
CD79a (JCB117) Mouse Monoclonal Antibody	179M-98	FDA UDI	Class I	Active
CD21 (EP3093) Rabbit Monoclonal Primary Antibody	121R-15	FDA UDI	Class I	Active
ROS1 (MRQ-68) Rabbit Monoclonal Antibody	469R-94-ASR	FDA UDI	Class I	Unknown
Factor XIIIa (EP3372) Rabbit Monoclonal Primary Antibody	251R-17	FDA UDI	Class I	Active
Hepatitis B Virus Surface Antigen (A10F1) Mouse Monoclonal Antibody	217M-26-ASR	FDA UDI	Class I	Active
MUC6 (MRQ-20) Mouse Monoclonal Antibody	293M-98	FDA UDI	Class I	Active
CD5 (SP19) Rabbit Monoclonal Antibody	205R-18	FDA UDI	Class I	Active
p120 Catenin (MRQ-5) Mouse Monoclonal Antibody	420M-17	FDA UDI	Class I	Active
IgA Rabbit Polyclonal Antibody	267A-16	FDA UDI	Class I	Active
CD23 (SP23) Rabbit Monoclonal Antibody	123R-14	FDA UDI	Class I	Active
Granzyme B Rabbit Polyclonal Antibody	760-4283	FDA UDI	Class I	Active
Annexin A1 (MRQ-3) Mouse Monoclonal Antibody	221M-17	FDA UDI	Class I	Active
Glucagon (EP74) Rabbit Monoclonal Primary Antibody	259R-14	FDA UDI	Class I	Active
Oct-4 (MRQ-10) Mouse Monoclonal Antibody	309M-17	FDA UDI	Class I	Active
Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody	760-4384	FDA UDI	Class I	Active
TAG-72 (B72.3) Mouse Monoclonal Antibody	337M-86	FDA UDI	Class I	Active
Collagen Type IV (CIV22) Mouse Monoclonal Antibody	239M-17	FDA UDI	Class I	Active
Cytokeratin 19 (EP72) Rabbit Monoclonal Primary Antibody	319R-25	FDA UDI	Class I	Active
Myeloperoxidase (SP72) Rabbit Monoclonal Antibody	289R-16	FDA UDI	Class I	Active
Cytokeratin 5 & 6 (D5/16B4) + TTF-1 (8G7G3/1) Mouse Monoclonal Antibody	902H-08	FDA UDI	Class I	Active
Renal Cell Carcinoma (PN-15) Mouse Monoclonal Antibody	329M-97	FDA UDI	Class I	Active
Cytokeratin 5 (EP1601Y) Rabbit Monoclonal Primary Antibody	305R-17	FDA UDI	Class I	Active
H3 K27M (RM192) Rabbit Monoclonal Antibody	492R-14	FDA UDI	Class I	Active
CD8 (C8/144B) Mouse Monoclonal Antibody	108M-98	FDA UDI	Class I	Active
p27/Kip1 (SX53G8) Mouse Monoclonal Antibody	427M-98	FDA UDI	Class I	Active
Annexin A1 (MRQ-3) Mouse Monoclonal Antibody	221M-14	FDA UDI	Class I	Active
Myoglobin Rabbit Polyclonal Antibody	297A-78	FDA UDI	Class I	Active
Treponema pallidum Rabbit Polyclonal Antibody	397A-15-ASR	FDA UDI	Class I	Active
Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody	760-2671	FDA UDI	Class I	Unknown
Cytokeratin, LMW (AE1) Mouse Monoclonal Antibody	301M-18	FDA UDI	Class I	Active
CD31 (EP78) Rabbit Monoclonal Primary Antibody	131R-28	FDA UDI	Class I	Active
Carbonic Anhydrase IX (CA IX)(EP161) Rabbit Monoclonal Primary Antibody	379R-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.