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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 15 of 44

Device	Model / Reference	Registries	Class	Status
CD20 (SP32) Rabbit Monoclonal Antibody	120R-14	FDA UDI	Class I	Active
Desmin (EP15) Rabbit Monoclonal Primary Antibody	243R-14	FDA UDI	Class I	Active
PLAP (NB10) Mouse Monoclonal Antibody	321M-17	FDA UDI	Class I	Active
CD2 (MRQ-11) Mouse Monoclonal Antibody	102M-16	FDA UDI	Class I	Active
PSAP (PASE/4LJ) Mouse Monoclonal Antibody	326M-14	FDA UDI	Class I	Active
Cytokeratin (34betaE12) Mouse Monoclonal Antibody	334M-88	FDA UDI	Class I	Active
CD34 (QBEnd/10) Mouse Monoclonal Antibody	134M-15	FDA UDI	Class I	Active
Lambda (EP172) Rabbit Monoclonal Primary Antibody	277R-18	FDA UDI	Class I	Active
Galectin-3 (9C4) Mouse Monoclonal Antibody	255M-15	FDA UDI	Class I	Active
IgG4 (EP138) Rabbit Monoclonal Primary Antibody	367R-18	FDA UDI	Class I	Active
Cytokeratin, LMW (AE1) Mouse Monoclonal Antibody	301M-17	FDA UDI	Class I	Active
Gastrin Rabbit Polyclonal Antibody	256A-17	FDA UDI	Class I	Active
Hepatitis B Virus Core Antigen Rabbit Polyclonal Antibody	216A-14-ASR	FDA UDI	Class I	Active
Glycophorin A (GA-R2) Mouse Monoclonal Antibody	260M-14	FDA UDI	Class I	Active
CD23 (MRQ-57) Mouse Monoclonal Antibody	123M-28	FDA UDI	Class I	Active
Vimentin (EP21) Rabbit Monoclonal Primary Antibody	347R-27	FDA UDI	Class I	Active
CD5 (EP77) Rabbit Monoclonal Primary Antibody	205R-27	FDA UDI	Class I	Active
PAX-5 (EP156) Rabbit Monoclonal Primary Antibody	312R-20	FDA UDI	Class I	Active
CD33 (PWS44) Mouse Monoclonal Antibody	133M-16	FDA UDI	Class I	Active
Thrombomodulin (1009) Mouse Monoclonal Antibody	339M-15	FDA UDI	Class I	Active
L1 (Cytoactiv) Mouse Monoclonal Antibody	498M-16-ASR	FDA UDI	Class I	Active
S100P (16/f5) Mouse Monoclonal Antibody	376M-97	FDA UDI	Class I	Active
NSE (MRQ-55) Mouse Monoclonal Antibody	306M-25	FDA UDI	Class I	Active
Arginase-1 (EP261) Rabbit Monoclonal Primary Antibody	380R-27	FDA UDI	Class I	Active
Uroplakin III (SP73) Rabbit Monoclonal Antibody	345R-15	FDA UDI	Class I	Active
CD71 (EP232) Rabbit Monoclonal Primary Antibody	171R-16	FDA UDI	Class I	Active
Myosin, Smooth Muscle (EP166) Rabbit Monoclonal Primary Antibody	298R-17	FDA UDI	Class I	Active
CA 125 (OC125) Mouse Monoclonal Antibody	325M-17	FDA UDI	Class I	Active
Cytokeratin 19 (EP72) Rabbit Monoclonal Primary Antibody	319R-24	FDA UDI	Class I	Active
Cytokeratin, HMW (AE3) Mouse Monoclonal Antibody	303M-15	FDA UDI	Class I	Active
Factor VIII-R Ag. Rabbit Polyclonal Antibody	250A-17	FDA UDI	Class I	Active
p63 (EP174) Rabbit Monoclonal Primary Antibody	482R-16	FDA UDI	Class I	Active
Uroplakin III (AU-1) Mouse Monoclonal Antibody	345M-16	FDA UDI	Class I	Active
Actin, Muscle Specific (HHF35) Mouse Monoclonal Antibody	201M-94	FDA UDI	Class I	Active
MART-1 (Melan A) (M2-7C10) Mouse Monoclonal Antibody	281M-90	FDA UDI	Class I	Active
Factor VIII-R Ag Rabbit Polyclonal Antibody	760-2642	FDA UDI	Class I	Active
H3 K36M (RM193) Rabbit Monoclonal Antibody	495R-16	FDA UDI	Class I	Active
GLUT1 Rabbit Polyclonal Antibody	355A-15	FDA UDI	Class I	Active
TTF-1 (EP229) Rabbit Monoclonal Primary Antibody	343R-14	FDA UDI	Class I	Active
Melanoma Associated Antigen (PNL2) Mouse Monclonal Antibody	760-4528	FDA UDI	Class I	Active
PNL2 (PNL2) Mouse Monoclonal Antibody	365M-96	FDA UDI	Class I	Active
ARID1A (EP303) Rabbit Monoclonal Primary Antibody	407R-17-ASR	FDA UDI	Class I	Unknown
IgA Rabbit Polyclonal Antibody	267A-17	FDA UDI	Class I	Active
PSMA (EP192) Rabbit Monoclonal Primary Antibody	327R-14	FDA UDI	Class I	Active
CD14 (EPR3653) Rabbit Monoclonal Primary Antibody	114R-14	FDA UDI	Class I	Active
Estrogen Receptor (EP1) Rabbit Monoclonal Primary Antibody	249R-25-ASR	FDA UDI	Class I	Active
IMP3 (EP286) Rabbit Monoclonal Primary Antibody	433R-17	FDA UDI	Class I	Active
Herpes Simplex Virus I (10A3) Mouse Monoclonal Antibody	361M-18-ASR	FDA UDI	Class I	Active
CD71 (EP232) Rabbit Monoclonal Primary Antibody	171R-18	FDA UDI	Class I	Active
Cytokeratin 5 & 6 (EP24 & EP67) Rabbit Monoclonal Primary Antibody	356R-15	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.