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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 2 of 44

Device	Model / Reference	Registries	Class	Status
CD103 (EP206) Rabbit Monoclonal Primary Antibody	437R-17	FDA UDI	Class I	Active
PAX-7 (MRQ-69) Mouse Monoclonal Antibody	481M-98	FDA UDI	Class I	Unknown
SDHB (EP288) Rabbit Monoclonal Primary Antibody	466R-15	FDA UDI	Class I	Active
Spectrin (RBC2/3D5) Mouse Monoclonal Antibody	760-4274	FDA UDI	Class I	Active
Stathmin (SP49) Rabbit Monoclonal Antibody	394R-18	FDA UDI	Class I	Active
ACTH Rabbit Polyclonal Antibody	206A-78	FDA UDI	Class I	Active
COX-2 (SP21) Rabbit Monoclonal Antibody	240R-17	FDA UDI	Class I	Active
Kappa (EP171) Rabbit Monoclonal Primary Antibody	274R-16	FDA UDI	Class I	Active
Ep-CAM/Epithelial Specific Antigen (MOC-31) Mouse Monoclonal Antibody	248M-17	FDA UDI	Class I	Active
Myogenin (EP162) Rabbit Monoclonal Primary Antibody	296R-16	FDA UDI	Class I	Active
PGP 9.5 Rabbit Polyclonal Antibody	318A-17	FDA UDI	Class I	Active
CA-125 (OC125) Mouse Monoclonal Antibody	325M-16	FDA UDI	Class I	Active
IgD (EP173) Rabbit Monoclonal Primary Antibody	268R-14	FDA UDI	Class I	Active
IgA Rabbit Polyclonal Antibody	267A-15	FDA UDI	Class I	Active
Mammaglobin Cocktail (304-1A5 & 31A5) Mouse & Rabbit Cocktail Antibody	280C-16	FDA UDI	Class I	Active
IMP3 (EP286) Rabbit Monoclonal Primary Antibody	433R-14	FDA UDI	Class I	Active
GCDFP-15 (23A3) Mouse Monoclonal Antibody	257M-17	FDA UDI	Class I	Active
EMA (E29) Mouse Monoclonal Antibody	247M-96	FDA UDI	Class I	Active
EGFR (EP22) Rabbit Monoclonal Primary Antibody	414R-27-ASR	FDA UDI	Class I	Active
Cytokeratin 5 & 6 (EP24 & EP67) Rabbit Monoclonal Primary Antibody	356R-14	FDA UDI	Class I	Active
Factor VIII-R Ag. Rabbit Polyclonal Antibody	250A-18	FDA UDI	Class I	Active
Kappa (EP171) Rabbit Monoclonal Primary Antibody	274R-15	FDA UDI	Class I	Active
A-1-Antitrypsin Rabbit Polyclonal Antibody	760-2605	FDA UDI	Class I	Active
CD8 (SP16) Rabbit Monoclonal Antibody	108R-17	FDA UDI	Class I	Active
MUC1 (EP85) Rabbit Monoclonal Primary Antibody	290R-18	FDA UDI	Class I	Active
Toxoplasma gondii Rabbit Polyclonal Antibody	220A-18-ASR	FDA UDI	Class I	Active
PD-L1 (28-8) Rabbit Monoclonal Primary Antibody	438R-15-ASR	FDA UDI	Class I	Active
HGAL (MRQ-49) Mouse Monoclonal Antibody	375M-94	FDA UDI	Class I	Active
L1 (Cytoactiv) Mouse Monoclonal Antibody	498M-14-ASR	FDA UDI	Class I	Active
Cytokeratin 5 & 6 (D5 & 16B4) Mouse Monoclonal Antibody	356M-17	FDA UDI	Class I	Active
S100 beta (EP32) Rabbit Monoclonal Primary Antibody	449R-16	FDA UDI	Class I	Active
LH Rabbit Polyclonal Antibody	209A-17	FDA UDI	Class I	Active
Collagen Type IV (CIV22) Mouse Monoclonal Antibody	239M-18	FDA UDI	Class I	Active
Neurofilament (2F11) Mouse Monoclonal Antibody	760-2661	FDA UDI	Class I	Active
p57/Kip2 (Kp10) Mouse Monoclonal Antibody	760-4617	EUDAMEDFDA UDI	Class I	Active
CD7 (EP132) Rabbit Monoclonal Primary Antibody	107R-16	FDA UDI	Class I	Active
Varicella Zoster Virus (SG1-1, SG1-SG4, NCP-1 & IE-62) Mouse Monoclonal Antibody	364M-17-ASR	FDA UDI	Class I	Active
Cadherin-17 (SP183) Rabbit Monoclonal Antibody	378R-14	FDA UDI	Class I	Active
CD5 (SP19) Rabbit Monoclonal Antibody	205R-17	FDA UDI	Class I	Active
CD57 (NK-1) Mouse Monoclonal Antibody	760-2626	FDA UDI	Class I	Active
TROP2 (EP431) Rabbit Monoclonal Primary Antibody	465R-16	FDA UDI	Class I	Active
HGAL (MRQ-49) Mouse Monoclonal Antibody	375M-95	FDA UDI	Class I	Active
CD57 (NK-1) Mouse Monoclonal Antibody	157M-98	FDA UDI	Class I	Active
Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody	468R-16	FDA UDI	Class I	Unknown
Lysozyme Rabbit Polyclonal Antibody	278A-14	FDA UDI	Class I	Active
p27Kip1 (SX53G8) Mouse Monoclonal Antibody	427M-94	FDA UDI	Class I	Active
Cytokeratin 5/14 (EP1601Y/LL002) Rabbit and Mouse Monoclonal Primary Antibody	760-4939	FDA UDI	Class I	Active
Hepatitis B Virus Surface Antigen (S1-210) Mouse Monoclonal Antibody	217M-17-ASR	FDA UDI	Class I	Active
FLI-1 (MRQ-1) Mouse Monoclonal Antibody	254M-14	FDA UDI	Class I	Active
CD45RO (UCHL-1) Mouse Monoclonal Antibody	147M-98	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.