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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 17 of 44

Device	Model / Reference	Registries	Class	Status
Cytokeratin 14 (LL002) Mouse Monoclonal Antibody	760-4251	FDA UDI	Class I	Active
CD44 (MRQ-13) Mouse Monoclonal Antibody	144M-94	FDA UDI	Class I	Active
LEF1 (EP310) Rabbit Monoclonal Primary Antibody	442R-17	FDA UDI	Class I	Active
PAX-8 (SP348) Rabbit Monoclonal Antibody	363R-37	FDA UDI	Class I	Active
Uroplakin III (SP73) Rabbit Monoclonal Antibody	345R-14	FDA UDI	Class I	Active
Caldesmon (E89) Rabbit Monoclonal Primary Antibody	230R-16	FDA UDI	Class I	Active
TTF-1 (EP229) Rabbit Monoclonal Primary Antibody	343R-16	FDA UDI	Class I	Active
BCL6 (EP278) Rabbit Monoclonal Primary Antibody	227R-28	FDA UDI	Class I	Active
PU.1 (EPR3158Y) Rabbit Monoclonal Primary Antibody	328R-15	FDA UDI	Class I	Active
Myosin, Smooth Muscle (EP166) Rabbit Monoclonal Primary Antibody	298R-15	FDA UDI	Class I	Active
Hepatitis B Virus Core Antigen Rabbit Polyclonal Antibody	216A-16-ASR	FDA UDI	Class I	Active
CD14 (EPR3653) Rabbit Monoclonal Primary Antibody	114R-18	FDA UDI	Class I	Active
Parvovirus B19 (R92F6) Mouse Monoclonal Antibody	218M-14-ASR	FDA UDI	Class I	Active
PD-1 (EP239) Rabbit Monoclonal Primary Antibody	315R-14	FDA UDI	Class I	Active
GLUT1 Rabbit Polyclonal Antibody	355A-16	FDA UDI	Class I	Active
Somatostatin (EP130) Rabbit Monoclonal Primary Antibody	332R-14	FDA UDI	Class I	Active
MSH6 (SP93) Rabbit Monoclonal Antibody	287R-27-ASR	FDA UDI	Class I	Active
Nestin (10C2) Mouse Monoclonal Antibody	388M-16	FDA UDI	Class I	Active
Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody	340M-18	FDA UDI	Class I	Active
TFE3 (MRQ-37) Rabbit Monoclonal Antibody	354R-14	FDA UDI	Class I	Active
CD99 (EPR3097Y) Rabbit Monoclonal Primary Antibody	199R-15	FDA UDI	Class I	Active
S100A1 (EP184) Rabbit Monoclonal Primary Antibody	408R-17	FDA UDI	Class I	Active
Prostein (EP381) Rabbit Monoclonal Primary Antibody	450R-17	FDA UDI	Class I	Active
Peripherin (8G2) Mouse Monoclonal Antibody	476M-15	FDA UDI	Class I	Active
Carbonic Anhydrase IX (CA IX) (MRQ-54) Mouse Monoclonal Antibody	379M-14	FDA UDI	Class I	Active
CD8 (C8/144B) Mouse Monoclonal Antibody	108M-94	FDA UDI	Class I	Active
COX-2 (SP21) Rabbit Monoclonal Antibody	240R-14	FDA UDI	Class I	Active
ALK Protein (ALK-1) Mouse Monoclonal Antibody	204M-14	FDA UDI	Class I	Active
MLH1 (M1) Mouse Monoclonal Antibody	285M-26-ASR	FDA UDI	Class I	Active
MDM2 (IF2) Mouse Monoclonal Antibody	479M-95	FDA UDI	Class I	Unknown
CD79a (SP18) Rabbit Monoclonal Antibody	179R-15	FDA UDI	Class I	Active
CD30 (Ber-H2) Mouse Monoclonal Antibody	130M-98	FDA UDI	Class I	Active
Hepatitis B Virus Surface Antigen (A10F1) Mouse Monoclonal Antibody	217M-24-ASR	FDA UDI	Class I	Active
CD99 (EPR3097Y) Rabbit Monoclonal Primary Antibody	199R-17	FDA UDI	Class I	Active
Calretinin Rabbit Polyclonal Antibody	232A-75	FDA UDI	Class I	Active
MUC2 (MRQ-18) Mouse Monoclonal Antibody	760-4388	FDA UDI	Class I	Active
MSH6 (SP93) Rabbit Monoclonal Antibody	287R-25-ASR	FDA UDI	Class I	Active
MUC2 (MRQ-18) Mouse Monoclonal Antibody	291M-15	FDA UDI	Class I	Active
CA-125 (OC125) Mouse Monoclonal Antibody	760-2610	FDA UDI	Class I	Active
ARID1A (EP303) Rabbit Monoclonal Primary Antibody	407R-16-ASR	FDA UDI	Class I	Unknown
BCL2 (124) Mouse Monoclonal Antibody	226M-98	FDA UDI	Class I	Active
Cytokeratin 7 (OV-TL 12/30) Mouse Monoclonal Antibody	307M-90	FDA UDI	Class I	Active
CD43 (MT1) Mouse Monoclonal Antibody	143M-15	FDA UDI	Class I	Active
MART-1 (M2-7C10) + Tyrosinase (T311) Mouse Monoclonal Antibody	903H-08	FDA UDI	Class I	Active
MDM2 (IF2) Mouse Monoclonal Antibody	479M-94	FDA UDI	Class I	Unknown
Cytokeratin 14 (SP53) Rabbit Monoclonal Antibody	314R-18	FDA UDI	Class I	Active
Desmin (EP15) Rabbit Monoclonal Primary Antibody	243R-18	FDA UDI	Class I	Active
Progesterone Receptor (Y85) Rabbit Monoclonal Primary Antibody	323R-15-ASR	FDA UDI	Class I	Active
ACTH Rabbit Polyclonal Antibody	206A-76	FDA UDI	Class I	Active
Somatostatin (EP130) Rabbit Monoclonal Primary Antibody	332R-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.