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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 19 of 44

Device	Model / Reference	Registries	Class	Status
CD8 (SP16) Rabbit Monoclonal Antibody	108R-15	FDA UDI	Class I	Active
CD11c (5D11) Mouse Monoclonal Antibody	111M-14	FDA UDI	Class I	Active
Claudin 1 Rabbit Polyclonal Antibody	359A-18	FDA UDI	Class I	Active
TSH Rabbit Polyclonal Antibody	760-2709	FDA UDI	Class I	Active
HER2/NEU (EP3) Rabbit Monoclonal Primary Antibody	237R-25	FDA UDI	Class I	Unknown
CD63 (NKI/C3) Mouse Monoclonal Antibody	263M-18	FDA UDI	Class I	Active
HGAL (MRQ-49) Mouse Monoclonal Antibody	375M-97	FDA UDI	Class I	Active
MART-1 (M2-7C10) + Tyrosinase (T311) Mouse Monoclonal Antibody	903H-07	FDA UDI	Class I	Active
Calcitonin Rabbit Polyclonal Antibody	229A-16	FDA UDI	Class I	Active
Napsin A Rabbit Polyclonal Antibody	352A-75	FDA UDI	Class I	Active
Prolactin (EP193) Rabbit Monoclonal Primary Antibody	210R-18	FDA UDI	Class I	Active
Inhibin, alpha (MRQ-63) Rabbit Monoclonal Antibody	271R-28	FDA UDI	Class I	Active
Prolactin (EP193) Rabbit Monoclonal Primary Antibody	210R-16	FDA UDI	Class I	Active
Tryptase (G3) Mouse Monoclonal Antibody	342M-14	FDA UDI	Class I	Active
MUC1 (MRQ-17) Mouse Monoclonal Antibody	290M-15	FDA UDI	Class I	Active
Perforin (MRQ-23) Mouse Monoclonal Antibody	316M-18	FDA UDI	Class I	Active
CD44 (MRQ-13) Mouse Monoclonal Antibody	144M-97	FDA UDI	Class I	Active
PAX-8 (SP348) Rabbit Monoclonal Antibody	363R-35	FDA UDI	Class I	Active
H3 K27M (RM192) Rabbit Monoclonal Antibody	492R-15	FDA UDI	Class I	Active
C4d (SP91) Rabbit Monoclonal Antibody	404R-18	FDA UDI	Class I	Active
Myeloperoxidase (EP151) Rabbit Monoclonal Primary Antibody	289R-28	FDA UDI	Class I	Active
PLAP (NB10) Mouse Monoclonal Antibody	321M-18	FDA UDI	Class I	Active
GH (EP267) Rabbit Monoclonal Primary Antibody	208R-16	FDA UDI	Class I	Active
Uroplakin III (AU-1) Mouse Monoclonal Antibody	345M-14	FDA UDI	Class I	Active
Myeloperoxidase (EP151) Rabbit Monoclonal Primary Antibody	289R-26	FDA UDI	Class I	Active
CD71 (MRQ-48) Mouse Monoclonal Antibody	171M-97	FDA UDI	Class I	Active
PD-L1 (ZR3) Rabbit Monoclonal Antibody	438R-27-ASR	FDA UDI	Class I	Active
S100A1 (EP184) Rabbit Monoclonal Primary Antibody	408R-18	FDA UDI	Class I	Active
GCDFP-15 (23A3) Mouse Monoclonal Antibody	257M-14	FDA UDI	Class I	Active
PHOX2B (EP312) Rabbit Monoclonal Primary Antibody	422R-14	FDA UDI	Class I	Active
CD3 Rabbit Polyclonal Antibody	103A-70	FDA UDI	Class I	Active
PSMA (EP192) Rabbit Monoclonal Primary Antibody	327R-17	FDA UDI	Class I	Active
Cytokeratin 5 (EP1601Y) Rabbit Monoclonal Primary Antibody	305R-16	FDA UDI	Class I	Active
Myogenin (F5D) Mouse Monoclonal Antibody	760-2832	FDA UDI	Class I	Active
SOX-2 (SP76) Rabbit Monoclonal Antibody	371R-16	FDA UDI	Class I	Active
Myogenin (EP162) Rabbit Monoclonal Primary Antibody	296R-14	FDA UDI	Class I	Active
Oct-2 (MRQ-2) Mouse Monoclonal Antibody	308M-16	FDA UDI	Class I	Active
PSAP (PASE/4LJ) Mouse Monoclonal Antibody	326M-16	FDA UDI	Class I	Active
PD-1 (EP239) Rabbit Monoclonal Primary Antibody	315R-15	FDA UDI	Class I	Active
CD57 (NK-1) Mouse Monoclonal Antibody	157M-94	FDA UDI	Class I	Active
p53 (DO7) Mouse Monoclonal Antibody	453M-95	FDA UDI	Class I	Active
Cadherin 17 (SP183) Rabbit Monoclonal Primary Antibody	760-4865	FDA UDI	Class I	Active
GH (EP267) Rabbit Monoclonal Primary Antibody	208R-15	FDA UDI	Class I	Active
BOB.1 (SP92) Rabbit Monoclonal Antibody	294R-15	FDA UDI	Class I	Active
Treponema pallidum Rabbit Polyclonal Antibody	397A-14-ASR	FDA UDI	Class I	Active
EGFR (EP22) Rabbit Monoclonal Primary Antibody	414R-27	FDA UDI	Class I	Unknown
Cytokeratin (34betaE12) Mouse Monoclonal Antibody	334M-80	FDA UDI	Class I	Active
Carbonic Anhydrase IX (EP161) Rabbit Monoclonal Primary Antibody	760-6080	FDA UDI	Class I	Active
CD61 (EP65) Rabbit Monoclonal Primary Antibody	161R-15	FDA UDI	Class I	Active
p120 Catenin (MRQ-5) Mouse Monoclonal Antibody	420M-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.