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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 10 of 44

Device	Model / Reference	Registries	Class	Status
Adenovirus (20/11 & 2/6) Mouse Monoclonal Antibody	212M-17-ASR	FDA UDI	Class I	Active
IgD Rabbit Polyclonal Antibody	268A-16	FDA UDI	Class I	Active
MUC2 (MRQ-18) Mouse Monoclonal Antibody	291M-18	FDA UDI	Class I	Active
Myogenin (F5D) Mouse Monoclonal Antibody	296M-15	FDA UDI	Class I	Active
Factor VIII-R Ag. Rabbit Polyclonal Antibody	250A-16	FDA UDI	Class I	Active
CD23 (MRQ-57) Mouse Monoclonal Antibody	123M-24	FDA UDI	Class I	Active
ROS1 (MRQ-68) Rabbit Monoclonal Antibody	469R-94	FDA UDI	Class I	Unknown
Alpha-Fetoprotein Rabbit Polyclonal Antibody	203A-17	FDA UDI	Class I	Active
Cytokeratin 17 (EP98) Rabbit Monoclonal Primary Antibody	317R-15	FDA UDI	Class I	Active
Androgen Receptor (EP120) Rabbit Monoclonal Primary Antibody	200R-26	FDA UDI	Class I	Active
Nerve Growth Factor Receptor (NGFR) (MRQ-21) Mouse Monoclonal Antibody	304M-18	FDA UDI	Class I	Active
C4d Rabbit Polyclonal Antibody	404A-15	FDA UDI	Class I	Active
TTF-1 (EP229) Rabbit Monoclonal Primary Antibody	343R-18	FDA UDI	Class I	Active
Glial Fibrillary Acidic Protein (GFAP) (SP78) Rabbit Monoclonal Antibody	258R-28	FDA UDI	Class I	Active
CITED1 (5H6) Mouse Monoclonal Antibody	424M-18	FDA UDI	Class I	Active
BCL2 (124) Mouse Monoclonal Antibody	226M-97	FDA UDI	Class I	Active
Microphthalmia Transcription Factor (MiTF) (C5/D5) Mouse Monoclonal Antibody	284M-98	FDA UDI	Class I	Active
Carbonic Anhydrase IX (CA IX)(MRQ-54) Mouse Monoclonal Antibody	379M-17	FDA UDI	Class I	Active
hCG Rabbit Polyclonal Antibody	234A-18	FDA UDI	Class I	Active
CA19-9 (121SLE) Mouse Monoclonal Antibody	399M-17	FDA UDI	Class I	Active
Thyroglobulin (MRQ-41) Mouse Monoclonal Antibody	340M-95	FDA UDI	Class I	Active
Herpes Simplex Virus II (3C5.2) Mouse Monoclonal Antibody	362M-10-ASR	FDA UDI	Class I	Active
Progesterone Receptor (SP42) Rabbit Monoclonal Antibody	323R-36-ASR	FDA UDI	Class I	Active
PGP 9.5 Rabbit Polyclonal Antibody	760-4434	FDA UDI	Class I	Active
EZH2 (11) Mouse Monoclonal Antibody	415M-15	FDA UDI	Class I	Active
PSA (EP109) Rabbit Monoclonal Primary Antibody	324R-17	FDA UDI	Class I	Active
CD117, c-kit (YR145) Rabbit Monoclonal Primary Antibody	117R-18-ASR	FDA UDI	Class I	Active
IMP3 (EP286) Rabbit Monoclonal Primary Antibody	433R-16	FDA UDI	Class I	Active
Estrogen Receptor (EP1) Rabbit Monoclonal Primary Antibody	249R-26-ASR	FDA UDI	Class I	Active
CD7 (MRQ-56) Mouse Monoclonal Antibody	107M-28	FDA UDI	Class I	Active
CD11c (EP157) Rabbit Monoclonal Primary Antibody	111R-15	FDA UDI	Class I	Active
FSH Rabbit Polyclonal Antibody	760-2710	FDA UDI	Class I	Active
MUC2 (MRQ-18) Mouse Monoclonal Antibody	291M-14	FDA UDI	Class I	Active
TdT Rabbit Polyclonal Antibody	338A-74	FDA UDI	Class I	Active
Mammaglobin (31A5) Rabbit Monoclonal Antibody	760-4263	FDA UDI	Class I	Active
CD5 (4C7) Mouse Monoclonal Antibody	205M-15	FDA UDI	Class I	Active
CD34 (EP88) Rabbit Monoclonal Primary Antibody	134R-14	FDA UDI	Class I	Active
NGFR (Nerve Growth Factor Receptor) (MRQ-21) Mouse Monoclonal Antibody	760-4391	FDA UDI	Class I	Active
CD19 (EP169) Rabbit Monoclonal Primary Antibody	119R-15	FDA UDI	Class I	Active
Fascin (55k-2) Mouse Monoclonal Antibody	252M-14	FDA UDI	Class I	Active
Glypican-3 (1G12) Mouse Monoclonal Antibody	261M-97	FDA UDI	Class I	Active
GCDFP-15 (23A3) Mouse Monoclonal Antibody	257M-16	FDA UDI	Class I	Active
SOX-10 Rabbit Polyclonal Antibody	383A-78	FDA UDI	Class I	Active
Perforin (MRQ-23) Mouse Monoclonal Antibody	760-4394	FDA UDI	Class I	Active
Renal Cell Carcinoma (PN-15) Mouse Monoclonal Antibody	760-4273	FDA UDI	Class I	Active
TRAcP (9C5) Mouse Monoclonal Antibody	760-4275	FDA UDI	Class I	Active
TAG-72 (B72.3) Mouse Monoclonal Antibody	337M-88	FDA UDI	Class I	Active
P504s (13H4) Rabbit Monoclonal Antibody	504R-18-ASR	FDA UDI	Class I	Unknown
SOX-2 (SP76) Rabbit Monoclonal Antibody	371R-17	FDA UDI	Class I	Active
Napsin A Rabbit Polyclonal Antibody	352A-76	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.