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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 3 of 44

Device	Model / Reference	Registries	Class	Status
HHV-8 (13B10) Mouse Monoclonal Antibody	265M-18-ASR	FDA UDI	Class I	Active
CD8 (SP16) Rabbit Monoclonal Antibody	108R-16	FDA UDI	Class I	Active
Myogenin (F5D) Mouse Monoclonal Antibody	296M-16	FDA UDI	Class I	Active
CD8 (C8/144B) Mouse Monoclonal Antibody	108M-97	FDA UDI	Class I	Active
p21/WAF1 (DCS-60.2) Mouse Monoclonal Antibody	421M-15	FDA UDI	Class I	Active
CD117, c-kit (YR145) Rabbit Monoclonal Primary Antibody	117R-16-ASR	FDA UDI	Class I	Active
Human Placental Lactogen (hPL) Rabbit Polyclonal Antibody	266A-14	FDA UDI	Class I	Active
CD16 (SP175) Rabbit Monoclonal Antibody	116R-16	FDA UDI	Class I	Active
Mesothelin (EP140) Rabbit Monoclonal Primary Antibody	439R-17	FDA UDI	Class I	Active
MLH1 (G168-728) Mouse Monoclonal Antibody	285M-10	FDA UDI	Class I	Unknown
Carbonic Anhydrase IX (CA IX)(EP161) Rabbit Monoclonal Primary Antibody	379R-16	FDA UDI	Class I	Active
p21WAF1 (DCS-60.2) Mouse Monoclonal Antibody	421M-18	FDA UDI	Class I	Active
EGFR (EP22) Rabbit Monoclonal Primary Antibody	414R-28	FDA UDI	Class I	Unknown
MSH6 (44) Mouse Monoclonal Antibody	287M-15-ASR	FDA UDI	Class I	Active
CD34 (QBEnd/10) Mouse Monoclonal Antibody	134M-14	FDA UDI	Class I	Active
Neurofilament (EP79) Rabbit Monoclonal Primary Antibody	302R-15	FDA UDI	Class I	Active
Nerve Growth Factor Receptor (NGFR) (MRQ-21) Mouse Monoclonal Antibody	304M-15	FDA UDI	Class I	Active
C4d (SP91) Rabbit Monoclonal Antibody	404R-17	FDA UDI	Class I	Active
FLI-1 (MRQ-1) Mouse Monoclonal Antibody	254M-16	FDA UDI	Class I	Active
MUM1 (MRQ-8) Mouse Monoclonal Antibody	358M-16	FDA UDI	Class I	Active
CD35 (EP197) Rabbit Monoclonal Primary Antibody	135R-15	FDA UDI	Class I	Active
Cytokeratin 20 (Ks20.8) Mouse Monoclonal Antibody	320M-16	FDA UDI	Class I	Active
Oct-2 (MRQ-2) Mouse Monoclonal Antibody	308M-15	FDA UDI	Class I	Active
SATB2 (SP281) Rabbit Monoclonal Primary Antibody	760-5052	FDA UDI	Class I	Active
IgG4 (EP138) Rabbit Monoclonal Primary Antibody	367R-14	FDA UDI	Class I	Active
INI-1 (MRQ-27) Mouse Monoclonal Antibody	760-4615	EUDAMEDFDA UDI	Class I	Active
CD21 (EP3093) Rabbit Monoclonal Primary Antibody	121R-14	FDA UDI	Class I	Active
CD2 (MRQ-11) Mouse Monoclonal Antibody	102M-17	FDA UDI	Class I	Active
CA19-9 (121SLE) Mouse Monoclonal Antibody	399M-15	FDA UDI	Class I	Active
Napsin A Rabbit Polyclonal Antibody	760-4446	FDA UDI	Class I	Active
MSH6 (SP93) Rabbit Monoclonal Antibody	287R-24-ASR	FDA UDI	Class I	Active
Prolactin (EP193) Rabbit Monoclonal Primary Antibody	210R-15	FDA UDI	Class I	Active
A-1-Antitrypsin Rabbit Polyclonal Antibody	223A-16	FDA UDI	Class I	Active
CD71 (MRQ-48) Mouse Monoclonal Antibody	171M-94	FDA UDI	Class I	Active
Smoothelin (R4A) Mouse Monoclonal Antibody	760-4592	FDA UDI	Class I	Active
Alpha-Fetoprotein Rabbit Polyclonal Antibody	203A-18	FDA UDI	Class I	Active
PNL2 (PNL2) Mouse Monoclonal Antibody	365M-98	FDA UDI	Class I	Active
Uroplakin III (AU-1) Mouse Monoclonal Antibody	345M-15	FDA UDI	Class I	Active
C4d Rabbit Polyclonal Antibody	404A-14	FDA UDI	Class I	Active
Calcitonin (SP17) Rabbit Monoclonal Antibody	229R-16	FDA UDI	Class I	Active
Hepatitis B Virus Surface Antigen (S1-210) Mouse Monoclonal Antibody	217M-18-ASR	FDA UDI	Class I	Active
CD30 (Ber-H2) Mouse Monoclonal Antibody	130M-95	FDA UDI	Class I	Active
Cytokeratin (35betaH11) Mouse Monoclonal Antibody	335M-98	FDA UDI	Class I	Active
TTF-1 (EP229) Rabbit Monoclonal Primary Antibody	343R-17	FDA UDI	Class I	Active
CD3 Rabbit Polyclonal Antibody	103A-76	FDA UDI	Class I	Active
MSH6 (SP93) Rabbit Monoclonal Antibody	287R-26-ASR	FDA UDI	Class I	Active
SOX-2 (SP76) Rabbit Monoclonal Antibody	371R-18	FDA UDI	Class I	Active
PNL2 (PNL2) Mouse Monoclonal Antibody	365M-97	FDA UDI	Class I	Active
Somatostatin Receptor 2A (EP149) Rabbit Monoclonal Primary Antibody	486R-18	FDA UDI	Class I	Active
COX-2 (SP21) Rabbit Monoclonal Antibody	240R-18	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.