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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 26 of 44

Device	Model / Reference	Registries	Class	Status
CD20 (L26) Mouse Monoclonal Antibody	120M-87	FDA UDI	Class I	Active
MyoD1 (EP212) Rabbit Monoclonal Primary Antibody	386R-16	FDA UDI	Class I	Active
IMP3 (EP286) Rabbit Monoclonal Primary Antibody	433R-18	FDA UDI	Class I	Active
GH Rabbit Polyclonal Antibody	208A-77	FDA UDI	Class I	Active
Nanog (EP225) Rabbit Monoclonal Primary Antibody	443R-14	FDA UDI	Class I	Active
Alpha-Fetoprotein Rabbit Polyclonal Antibody	203A-16	FDA UDI	Class I	Active
p57/Kip2 (Kp10) Mouse Monoclonal Antibody	457M-97	FDA UDI	Class I	Active
BOB.1 (SP92) Rabbit Monoclonal Antibody	294R-16	FDA UDI	Class I	Active
ERG (EP111) Rabbit Monoclonal Primary Antibody	434R-18	FDA UDI	Class I	Active
Synaptophysin (EP158) Rabbit Monoclonal Primary Antibody	336R-14	FDA UDI	Class I	Active
Stathmin (SP49) Rabbit Monoclonal Antibody	394R-16	FDA UDI	Class I	Active
Caldesmon (E89) Rabbit Monoclonal Primary Antibody	230R-18	FDA UDI	Class I	Active
SALL4 (6E3) Mouse Monoclonal Primary Antibody	760-4864	EUDAMEDFDA UDI	Class I	Active
CD30 (Ber-H2) Mouse Monoclonal Antibody	130M-96	FDA UDI	Class I	Active
CD13 (SP187) Rabbit Monoclonal Antibody	113R-15	FDA UDI	Class I	Active
Pit-1 (ZM385) Mouse Monoclonal Antibody	496M-17	FDA UDI	Class I	Active
Desmin (D33) Mouse Monoclonal Antibody	243M-18	FDA UDI	Class I	Active
Calponin (CALP) Mouse Monoclonal Antibody	231M-18	FDA UDI	Class I	Active
Tyrosine Hydroxylase (LNC1) Mouse Monoclonal Antibody	490M-17	FDA UDI	Class I	Active
L1 (Cytoactiv) Mouse Monoclonal Antibody	498M-17-ASR	FDA UDI	Class I	Active
Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal Antibodies	280C-14	FDA UDI	Class I	Active
Epstein-Barr Virus (MRQ-47) Rabbit Monoclonal Antibody	245R-16-ASR	FDA UDI	Class I	Active
CD3 (MRQ-39) Rabbit Monoclonal Antibody	103R-96	FDA UDI	Class I	Active
Napsin A Rabbit Polyclonal Antibody	352A-74	FDA UDI	Class I	Active
Hepatitis B Virus Surface Antigen (S1-210) Mouse Monoclonal Antibody	217M-15-ASR	FDA UDI	Class I	Active
CD99 (EPR3097Y) Rabbit Monoclonal Primary Antibody	199R-14	FDA UDI	Class I	Active
CD2 (MRQ-11) Mouse Monoclonal Antibody	102M-18	FDA UDI	Class I	Active
Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody	760-2671	FDA UDI	Class I	Active
CD117, c-kit (YR145) Rabbit Monoclonal Primary Antibody	117R-10-ASR	FDA UDI	Class I	Active
CD117, c-kit (YR145) Rabbit Monoclonal Primary Antibody	117R-17-ASR	FDA UDI	Class I	Active
MLH1 (M1) Mouse Monoclonal Antibody	285M-28-ASR	FDA UDI	Class I	Active
Peripherin (8G2) Mouse Monoclonal Antibody	476M-18	FDA UDI	Class I	Active
FoxP1 (SP133) Rabbit Monoclonal Antibody	350R-17	FDA UDI	Class I	Active
CMV (DDG9/CCH2) Mouse Monoclonal Antibody	213M-14-ASR	FDA UDI	Class I	Active
CD123 (6H6) Mouse Monoclonal Antibody	198M-17	FDA UDI	Class I	Active
Prolactin Rabbit Polyclonal Antibody	210A-16	FDA UDI	Class I	Active
Treponema pallidum Rabbit Polyclonal Antibody	397A-14	FDA UDI	Class I	Unknown
CA 125 (OC125) Mouse Monoclonal Antibody	325M-15	FDA UDI	Class I	Active
BG8, LewisY (F3) Mouse Monoclonal Antibody	228M-15	FDA UDI	Class I	Active
Carbonic Anhydrase IX (CA IX) (EP161) Rabbit Monoclonal Primary Antibody	379R-18	FDA UDI	Class I	Active
Cytokeratin 20 (Ks20.8) Mouse Monoclonal Antibody	320M-15	EUDAMEDFDA UDI	Class I	Active
A-1-Antitrypsin Rabbit Polyclonal Antibody	223A-18	FDA UDI	Class I	Active
Cytokeratin 5 & 6 (EP24 & EP67) Rabbit Monoclonal Primary Antibody	356R-18	FDA UDI	Class I	Active
Myoglobin Rabbit Polyclonal Antibody	297A-77	FDA UDI	Class I	Active
Toxoplasma gondii Rabbit Polyclonal Antibody	220A-17-ASR	FDA UDI	Class I	Active
Macrophage (HAM-56) Mouse Monoclonal Antibody	279M-15	FDA UDI	Class I	Active
LMO2 (SP51) Rabbit Monoclonal Antibody	370R-14	FDA UDI	Class I	Active
Synaptophysin Rabbit Polyclonal Antibody	336A-74	FDA UDI	Class I	Active
Chromogranin A (LK2H10) Mouse Monoclonal Antibody	238M-94	FDA UDI	Class I	Active
MLH1 (M1) Mouse Monoclonal Antibody	285M-27-ASR	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.