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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 (2152)

Page 1 of 44

Device	Model / Reference	Registries	Class	Status
Trilogy™ Pretreatment Solution	922P-04	EUDAMED	Class A	Active
Trilogy™ Pretreatment Solution	922P-05	EUDAMED	Class A	Active
Trilogy™ Pretreatment Solution	922P-07	EUDAMED	Class A	Active
Trilogy™ Pretreatment Solution	922P-06	EUDAMED	Class A	Active
Trilogy™ Pretreatment Solution	922P-09	EUDAMED	Class A	Active
Trilogy™ Pretreatment Solution	922P-10	EUDAMED	Class A	Active
Prolactin (EP193) Rabbit Monoclonal Primary Antibody	210R-17	FDA UDI	Class I	Active
ERG (EP111) Rabbit Monoclonal Primary Antibody	434R-14	FDA UDI	Class I	Active
Cadherin-17 (SP183) Rabbit Monoclonal Antibody	378R-18	FDA UDI	Class I	Active
Vimentin (V9) Mouse Monoclonal Antibody	347M-18	FDA UDI	Class I	Active
DOG1 (SP31) Rabbit Monoclonal Antibody	760-4590	EUDAMEDFDA UDI	Class I	Active
IgG4 (EP138) Rabbit Monoclonal Primary Antibody	367R-17	FDA UDI	Class I	Active
Progesterone Receptor (Y85) Rabbit Monoclonal Primary Antibody	323R-16-ASR	FDA UDI	Class I	Active
Calcitonin Rabbit Polyclonal Antibody	229A-14	FDA UDI	Class I	Active
p16INK4A (JC2) Mouse Monoclonal Antibody	416M-18-ASR	FDA UDI	Class I	Active
Hemoglobin A (EPR3608) Rabbit Monoclonal Primary Antibody	360R-14	FDA UDI	Class I	Active
CMV (DDG9/CCH2) Mouse Monoclonal Antibody	213M-17-ASR	FDA UDI	Class I	Active
Thrombomodulin (1009) Mouse Monoclonal Antibody	339M-17	FDA UDI	Class I	Active
Islet-1 (EP283) Rabbit Monoclonal Primary Antibody	431R-17	FDA UDI	Class I	Active
IgD Rabbit Polyclonal Antibody	760-4444	FDA UDI	Class I	Active
Pneumocystis jiroveci (carinii) (3F6) Mouse Monoclonal Antibody	219M-15-ASR	FDA UDI	Class I	Active
BCL2 (E17) Rabbit Monoclonal Primary Antibody	226R-16	FDA UDI	Class I	Active
CD7 (EP132) Rabbit Monoclonal Primary Antibody	107R-18	FDA UDI	Class I	Active
LIN28 (EP150) Rabbit Monoclonal Primary Antibody	464R-17	FDA UDI	Class I	Active
Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody	340M-16	FDA UDI	Class I	Active
PSA (ER-PR8) Mouse Monoclonal Antibody	324M-16	FDA UDI	Class I	Active
Olig2 (EP112) Rabbit Monoclonal Primary Antibody	387R-17	FDA UDI	Class I	Active
Cytokeratin 5 & 6 (D5 & 16B4) Mouse Monoclonal Antibody	356M-18	EUDAMEDFDA UDI	Class I	Active
PLAP (NB10) Mouse Monoclonal Antibody	321M-16	FDA UDI	Class I	Active
CD71 (EP232) Rabbit Monoclonal Primary Antibody	171R-14	FDA UDI	Class I	Active
Myeloperoxidase Rabbit Polyclonal Antibody	289A-75	FDA UDI	Class I	Active
CD34 (QBEnd/10) Mouse Monoclonal Antibody	134M-18	FDA UDI	Class I	Active
MUC5AC (MRQ-19) Mouse Monoclonal Antibody	292M-97	FDA UDI	Class I	Active
CD20 (L26) Mouse Monoclonal Antibody	120M-85	FDA UDI	Class I	Active
CD5 (4C7) Mouse Monoclonal Antibody	205M-18	FDA UDI	Class I	Active
H3 K36M (RM193) Rabbit Monoclonal Antibody	495R-14	FDA UDI	Class I	Active
PMS2 (EPR3947) Rabbit Monoclonal Primary Antibody	288R-18-ASR	FDA UDI	Class I	Active
CD8 (SP16) Rabbit Monoclonal Antibody	108R-14	FDA UDI	Class I	Active
Pneumocystis jiroveci (carinii) (3F6) Mouse Monoclonal Antibody	219M-17-ASR	FDA UDI	Class I	Active
Synaptophysin Rabbit Polyclonal Antibody	336A-77	FDA UDI	Class I	Active
IgA (EP170) Rabbit Monoclonal Primary Antibody	267R-16	FDA UDI	Class I	Active
GLUT1 Rabbit Polyclonal Antibody	355A-14	FDA UDI	Class I	Active
Renal Cell Carcinoma (PN-15) Mouse Monoclonal Antibody	329M-98	FDA UDI	Class I	Active
Neurofilament (2F11) Mouse Monoclonal Antibody	302M-17	FDA UDI	Class I	Active
Thyroglobulin (MRQ-41) Mouse Monoclonal Antibody	340M-97	FDA UDI	Class I	Active
Annexin A1 (MRQ-3) Mouse Monoclonal Antibody	760-4435	FDA UDI	Class I	Active
Progesterone Receptor (Y85) Rabbit Monoclonal Primary Antibody	323R-14-ASR	FDA UDI	Class I	Active
Adenovirus (20/11 & 2/6) Mouse Monoclonal Antibody	212M-16-ASR	FDA UDI	Class I	Active
Microphthalmia Transcription Factor (MiTF) (C5/D5) Mouse Monoclonal Antibody	284M-97	FDA UDI	Class I	Active
SOX-2 (SP76) Rabbit Monoclonal Antibody	371R-10	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.