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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 37 of 44

Device	Model / Reference	Registries	Class	Status
PAX-7 (MRQ-69) Mouse Monoclonal Antibody	481M-97	FDA UDI	Class I	Unknown
IgG Rabbit Polyclonal Antibody	269A-17	FDA UDI	Class I	Active
CD1a (EP3622) Rabbit Monoclonal Primary Antibody	101R-17	EUDAMEDFDA UDI	Class I	Active
HMB-45 + MART-1 (Melan A) (A103) + Tyrosinase (T311) Mouse Monoclonal Antibody	904H-08	FDA UDI	Class I	Active
LMO2 (SP51) Rabbit Monoclonal Antibody	370R-18	FDA UDI	Class I	Active
Hepatitis B Virus Surface Antigen (A10F1) Mouse Monoclonal Antibody	217M-26	FDA UDI	Class I	Unknown
CD123 (6H6) Mouse Monoclonal Antibody	198M-15	FDA UDI	Class I	Active
PU.1 (EPR3158Y) Rabbit Monoclonal Primary Antibody	328R-16	FDA UDI	Class I	Active
MSH6 (44) Mouse Monoclonal Antibody	287M-16	FDA UDI	Class I	Unknown
BCL2 (E17) Rabbit Monoclonal Primary Antibody	226R-15	FDA UDI	Class I	Active
Calcitonin Rabbit Polyclonal Antibody	229A-17	FDA UDI	Class I	Active
Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary Antibody	203R-17	FDA UDI	Class I	Active
CD57 (NK-1) Mouse Monoclonal Antibody	157M-96	FDA UDI	Class I	Active
SALL4 (EP299) Rabbit Monoclonal Primary Antibody	385R-18	FDA UDI	Class I	Active
MUM1 (EP190) Rabbit Monoclonal Primary Antibody	760-6082	EUDAMEDFDA UDI	Class I	Active
PHOX2B Rabbit Polyclonal Antibody	422A-18	FDA UDI	Class I	Active
CD57 (NK-1) Mouse Monoclonal Antibody	157M-97	FDA UDI	Class I	Active
ARID1A (EP303) Rabbit Monoclonal Primary Antibody	407R-15-ASR	FDA UDI	Class I	Unknown
FOXP1 (EP137) Rabbit Monoclonal Primary Antibody	350R-28	FDA UDI	Class I	Active
MDM2 (IF2) Mouse Monoclonal Antibody	479M-97	FDA UDI	Class I	Unknown
CEA Rabbit Polyclonal Antibody	236A-15	EUDAMEDFDA UDI	Class I	Active
TSH Rabbit Polyclonal Antibody	211A-15	FDA UDI	Class I	Active
Parvovirus B19 (R92F6) Mouse Monoclonal Antibody	218M-18-ASR	FDA UDI	Class I	Active
GCDFP-15 (EP1582Y) Rabbit Monoclonal Primary Antibody	257R-17	FDA UDI	Class I	Active
Glypican-3 (1G12) Mouse Monoclonal Antibody	760-4442	FDA UDI	Class I	Active
Nestin (10C2) Mouse Monoclonal Antibody	388M-15	FDA UDI	Class I	Active
Kappa (EP171) Rabbit Monoclonal Primary Antibody	274R-17	FDA UDI	Class I	Active
Myoglobin Rabbit Polyclonal Antibody	297A-76	FDA UDI	Class I	Active
Carbonic Anhydrase IX (CA IX) (MRQ-54) Mouse Monoclonal Antibody	379M-16	FDA UDI	Class I	Active
EGFR (SP84) Rabbit Monoclonal Antibody	414R-17-ASR	FDA UDI	Class I	Active
CD11c (5D11) Mouse Monoclonal Antibody	111M-17	FDA UDI	Class I	Active
CD23 (SP23) Rabbit Monoclonal Antibody	123R-16	FDA UDI	Class I	Active
C3d Rabbit Polyclonal Antibody	403A-74	FDA UDI	Class I	Active
CD71 (MRQ-48) Mouse Monoclonal Antibody	171M-95	EUDAMEDFDA UDI	Class I	Active
CD3 (MRQ-39) Rabbit Monoclonal Antibody	103R-95	FDA UDI	Class I	Active
Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary Antibody	203R-14	FDA UDI	Class I	Active
Hepatocyte Specific Antigen (Hep-Par1) (EP265) Rabbit Monoclonal Primary Antibod	264R-17	FDA UDI	Class I	Active
MAGEC2 (EP405) Rabbit Monoclonal Primary Antibody	477R-17	FDA UDI	Class I	Unknown
HMB-45 (HMB-45) Mouse Monoclonal Antibody	282M-95	EUDAMEDFDA UDI	Class I	Active
p53 (EP9) Rabbit Monoclonal Primary Antibody	453R-28	FDA UDI	Class I	Active
H3.3 G34W (RM263) Rabbit Monoclonal Antibody	493R-18	FDA UDI	Class I	Active
Progesterone Receptor (Y85) Rabbit Monoclonal Primary Antibody	323R-10-ASR	FDA UDI	Class I	Active
Parvovirus B19 (R92F6) Mouse Monoclonal Antibody	218M-17-ASR	FDA UDI	Class I	Active
CDK4 (DCS-31) Mouse Monoclonal Antibody	478M-96	FDA UDI	Class I	Unknown
SATB2 (EP281) Rabbit Monoclonal Primary Antibody	384R-16	EUDAMEDFDA UDI	Class C	Active
CD138/syndecan-1 (B-A38) Mouse Monoclonal Antibody	138M-15	EUDAMEDFDA UDI	Class C	Active
Cytokeratin Cocktail (AE1 & AE3) Mouse Monoclonal Antibody	313M-14	EUDAMEDFDA UDI	Class C	Active
E-cadherin (EP700Y) Rabbit Monoclonal Primary Antibody	246R-18	EUDAMEDFDA UDI	Class C	Active
Podoplanin (D2-40) Mouse Monoclonal Antibody	322M-16	EUDAMEDFDA UDI	Class C	Active
PRAME (EP461) Rabbit Monoclonal Primary Antibody	484R-14	EUDAMEDFDA UDI	Class C	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.