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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 33 of 44

Device	Model / Reference	Registries	Class	Status
Calretinin (SP13) Rabbit Monoclonal Antibody	232R-14	FDA UDI	Class I	Active
A-1-Antichymotrypsin Rabbit Polyclonal Antibody	222A-15	FDA UDI	Class I	Active
MUC2 (MRQ-18) Mouse Monoclonal Antibody	291M-17	FDA UDI	Class I	Active
MART-1 (Melan A) (A103) Mouse Monoclonal Antibody	281M-87	EUDAMEDFDA UDI	Class I	Active
Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary Antibody	203R-15	FDA UDI	Class I	Active
TTF-1 (EP229) Rabbit Monoclonal Primary Antibody	343R-15	FDA UDI	Class I	Active
Somatostatin Receptor 2A (EP149) Rabbit Monoclonal Primary Antibody	486R-14	FDA UDI	Class I	Active
Uroplakin III (SP73) Rabbit Monoclonal Antibody	345R-16	FDA UDI	Class I	Active
Calcitonin (SP17) Rabbit Monoclonal Antibody	229R-17	FDA UDI	Class I	Active
SOX-11 (MRQ-58) Mouse Monoclonal Antibody	382M-14	EUDAMEDFDA UDI	Class I	Active
Cytokeratin, HMW (AE3) Mouse Monoclonal Antibody	303M-18	FDA UDI	Class I	Active
PAX-5 (SP34) Rabbit Monoclonal Antibody	312R-18	FDA UDI	Class I	Active
CD23 (MRQ-57) Mouse Monoclonal Antibody	123M-27	FDA UDI	Class I	Active
Myogenin (EP162) Rabbit Monoclonal Primary Antibody	296R-15	FDA UDI	Class I	Active
CD3 (MRQ-39) Rabbit Monoclonal Antibody	103R-97	FDA UDI	Class I	Active
MLH1 (G168-728) Mouse Monoclonal Antibody	285M-16-ASR	FDA UDI	Class I	Active
PAX-5 (SP34) Rabbit Monoclonal Antibody	312R-16	FDA UDI	Class I	Active
FOXA1 (2F83) Mouse Monoclonal Antibody	405M-17	FDA UDI	Class I	Active
SDHB (EP288) Rabbit Monoclonal Primary Antibody	466R-16	FDA UDI	Class I	Active
PSAP (PASE/4LJ) Mouse Monoclonal Antibody	760-4272	FDA UDI	Class I	Active
CD44 (MRQ-13) Mouse Monoclonal Antibody	144M-96	FDA UDI	Class I	Active
Prolactin Rabbit Polyclonal Antibody	210A-15	FDA UDI	Class I	Active
Tyrosine Hydroxylase (LNC1) Mouse Monoclonal Antibody	490M-18	FDA UDI	Class I	Active
MUC5AC (MRQ-19) Mouse Monoclonal Antibody	292M-94	FDA UDI	Class I	Active
CD25 (4C9) Mouse Monoclonal Antibody	760-4439	FDA UDI	Class I	Active
p27Kip1 (SX53G8) Mouse Monoclonal Antibody	427M-97	FDA UDI	Class I	Active
PAX-7 (MRQ-69) Mouse Monoclonal Antibody	481M-94	FDA UDI	Class I	Unknown
Cytokeratin 17 (EP98) Rabbit Monoclonal Primary Antibody	317R-18	FDA UDI	Class I	Active
MSH6 (44) Mouse Monoclonal Antibody	287M-17-ASR	FDA UDI	Class I	Active
Cyclin D1 (EP12) Rabbit Monoclonal Primary Antibody	241R-46	FDA UDI	Class I	Active
Actin, Muscle Specific (HHF35) Mouse Monoclonal Antibody	760-2601	FDA UDI	Class I	Active
Galectin-3 (9C4) Mouse Monoclonal Antibody	255M-18	FDA UDI	Class I	Active
Glypican-3 (1G12) Mouse Monoclonal Antibody	261M-90	FDA UDI	Class I	Active
ERG (EP111) Rabbit Monoclonal Primary Antibody	434R-10	FDA UDI	Class I	Active
Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary Antibody	203R-16	FDA UDI	Class I	Active
CD123 (6H6) Mouse Monoclonal Antibody	198M-14	FDA UDI	Class I	Active
Lambda (Lamb14) Mouse Monoclonal Antibody	277M-94	FDA UDI	Class I	Active
CD11c (5D11) Mouse Monoclonal Antibody	111M-15	FDA UDI	Class I	Active
Alpha-Fetoprotein Rabbit Polyclonal Antibody	203A-14	FDA UDI	Class I	Active
p120 Catenin (MRQ-5) Mouse Monoclonal Antibody	420M-10	FDA UDI	Class I	Active
INSM1 (MRQ-70) Rabbit Monoclonal Antibody	475R-96	EUDAMEDFDA UDI	Class I	Active
Neutrophil Elastase (SP203) Rabbit Monoclonal Primary Antibody	760-4953	FDA UDI	Class I	Active
Varicella Zoster Virus (SG1-1, SG1-SG4, NCP-1 & IE-62) Mouse Monoclonal Antibody	364M-15-ASR	FDA UDI	Class I	Active
CD63 (NKI/C3) Mouse Monoclonal Antibody	263M-17	FDA UDI	Class I	Active
MUC6 (MRQ-20) Mouse Monoclonal Antibody	293M-96	FDA UDI	Class I	Active
CD7 (MRQ-56) Mouse Monoclonal Antibody	107M-26	FDA UDI	Class I	Active
Ki-67 (MRQ-64) Rabbit Monoclonal Antibody	275R-30	FDA UDI	Class I	Unknown
Parathyroid Hormone (PTH) (MRQ-31) Mouse Monoclonal Antibody	760-4532	FDA UDI	Class I	Active
PHOX2B (EP312) Rabbit Monoclonal Primary Antibody	422R-16	FDA UDI	Class I	Active
Glutamine Synthetase (GS-6) Mouse Monoclonal Antibody	389M-14	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.