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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 32 of 44

Device	Model / Reference	Registries	Class	Status
C4d Rabbit Polyclonal Antibody	404A-18	FDA UDI	Class I	Active
Myogenin (EP162) Rabbit Monoclonal Primary Antibody	296R-18	FDA UDI	Class I	Active
IgD (EP173) Rabbit Monoclonal Primary Antibody	268R-18	FDA UDI	Class I	Active
Granzyme B (EP230) Rabbit Monoclonal Primary Antibody	262R-14	FDA UDI	Class I	Active
MUM1 (MRQ-43) Rabbit Monoclonal Antibody	358R-77	FDA UDI	Class I	Active
Prolactin (EP193) Rabbit Monoclonal Primary Antibody	210R-14	FDA UDI	Class I	Active
TdT Rabbit Polyclonal Antibody	338A-75	EUDAMEDFDA UDI	Class I	Active
Villin (EP163) Rabbit Monoclonal Primary Antibody	346R-15	FDA UDI	Class I	Active
anti-SOX-2 (SP76) Rabbit Monoclonal Primary Antibody	760-4621	FDA UDI	Class I	Active
TLE1 (1F5) Mouse Monoclonal Antibody	401M-17	FDA UDI	Class I	Active
BCA-225 (Cu-18) Mouse Monoclonal Antibody	760-2607	FDA UDI	Class I	Active
Fascin (55k-2) Mouse Monoclonal Antibody	760-2702	FDA UDI	Class I	Active
Tryptase (G3) Mouse Monoclonal Antibody	342M-17	FDA UDI	Class I	Active
PGP 9.5 Rabbit Polyclonal Antibody	318A-15	FDA UDI	Class I	Active
CD138 (EP201) Rabbit Monoclonal Primary Antibody	138R-24	FDA UDI	Class I	Active
Cyclin D1 (EP12) Rabbit Monoclonal Primary Antibody	241R-45	FDA UDI	Class I	Active
Uroplakin III (AU-1) Mouse Monoclonal Antibody	345M-18	FDA UDI	Class I	Active
MUC5AC (MRQ-19) Mouse Monoclonal Antibody	292M-95	FDA UDI	Class I	Active
Lambda (Lamb14) Mouse Monoclonal Antibody	277M-95	FDA UDI	Class I	Active
H3 K36M (RM193) Rabbit Monoclonal Antibody	495R-18	FDA UDI	Class I	Active
PD-1 (EP239) Rabbit Monoclonal Primary Antibody	315R-17	FDA UDI	Class I	Active
IgD (EP173) Rabbit Monoclonal Primary Antibody	268R-16	FDA UDI	Class I	Active
Galectin-3 (9C4) Mouse Monoclonal Antibody	255M-16	FDA UDI	Class I	Active
Mammaglobin (31A5) Rabbit Monoclonal Antibody	280R-18	EUDAMEDFDA UDI	Class I	Active
Glucagon (EP74) Rabbit Monoclonal Primary Antibody	259R-17	FDA UDI	Class I	Active
Estrogen Receptor (SP1) Rabbit Monoclonal Antibody	249R-17-ASR	FDA UDI	Class I	Active
IgG Rabbit Polyclonal Antibody	269A-18	FDA UDI	Class I	Active
p21WAF1 (DCS-60.2) Mouse Monoclonal Antibody	421M-17	FDA UDI	Class I	Active
CD3 Rabbit Polyclonal Antibody	103A-77	FDA UDI	Class I	Active
Cyclin D1 (EP12) Rabbit Monoclonal Primary Antibody	241R-47	FDA UDI	Class I	Active
Calcitonin Rabbit Polyclonal Antibody	229A-15	FDA UDI	Class I	Active
Herpes Simplex Virus II Rabbit Polyclonal Antibody	362A-75-ASR	FDA UDI	Class I	Active
GLUT3 Rabbit Polyclonal Antibody	413A-14	FDA UDI	Class I	Active
CD2 (MRQ-11) Mouse Monoclonal Antibody	102M-14	EUDAMEDFDA UDI	Class I	Active
BCL2 (SP66) Rabbit Monoclonal Antibody	226R-24	FDA UDI	Class I	Active
Her2/Neu (EP3) Rabbit Monoclonal Primary Antibody	237R-24-ASR	FDA UDI	Class I	Active
Herpes Simplex Virus I (10A3) Mouse Monoclonal Antibody	361M-16-ASR	FDA UDI	Class I	Active
c-Myc (EP121) Rabbit Monoclonal Primary Antibody	395R-14	EUDAMEDFDA UDI	Class I	Active
Microphthalmia Transcription Factor (MiTF) (C5/D5) Mouse Monoclonal Antibody	284M-90	FDA UDI	Class I	Active
S100A1 (EP184) Rabbit Monoclonal Primary Antibody	408R-16	FDA UDI	Class I	Active
GCDFP-15 (EP1582Y) Rabbit Monoclonal Primary Antibody	257R-14	FDA UDI	Class I	Active
Tryptase (G3) Mouse Monoclonal Antibody	760-4276	FDA UDI	Class I	Active
CD71 (MRQ-48) Mouse Monoclonal Antibody	760-4589	FDA UDI	Class I	Active
MART-1 (Melan A) (A103) Mouse Monoclonal Antibody	281M-85	FDA UDI	Class I	Active
SALL4 (EP299) Rabbit Monoclonal Primary Antibody	385R-15	FDA UDI	Class I	Active
SDHB (EP288) Rabbit Monoclonal Primary Antibody	466R-14	FDA UDI	Class I	Active
CD33 (SP266) Rabbit Monoclonal Primary Antibody	760-4952	FDA UDI	Class I	Active
Epstein-Barr Virus (MRQ-47) Rabbit Monoclonal Antibody	245R-15	FDA UDI	Class I	Unknown
Pneumocystis jiroveci (carinii) (3F6) Mouse Monoclonal Antibody	219M-16-ASR	FDA UDI	Class I	Active
Herpes Simplex Virus I Rabbit Polyclonal Antibody	361A-17-ASR	EUDAMEDFDA 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.