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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 4 of 44

Device	Model / Reference	Registries	Class	Status
Microphthalmia Transcription Factor (MiTF) (C5/D5) Mouse Monoclonal Antibody	284M-95	FDA UDI	Class I	Active
Glycophorin A (GA-R2) Mouse Monoclonal Antibody	260M-15	FDA UDI	Class I	Active
Hepatitis B Virus Surface Antigen (A10F1) Mouse Monoclonal Antibody	217M-28-ASR	FDA UDI	Class I	Active
ARID1A (EP303) Rabbit Monoclonal Primary Antibody	407R-18-ASR	FDA UDI	Class I	Unknown
Hepatitis B Virus Core Antigen Rabbit Polyclonal Antibody	216A-18-ASR	FDA UDI	Class I	Active
p53 (SP5) Rabbit Monoclonal Antibody	453R-17	FDA UDI	Class I	Active
IgD Rabbit Polyclonal Antibody	268A-17	FDA UDI	Class I	Active
MUM1 (EP190) Rabbit Monoclonal Primary Antibody	358R-18	FDA UDI	Class I	Active
MLH1 (G168-728) Mouse Monoclonal Antibody	285M-14	FDA UDI	Class I	Unknown
MUM1 (MRQ-43) Rabbit Monoclonal Antibody	358R-74	FDA UDI	Class I	Active
KBA.62 (KBA.62) Mouse Monoclonal Antibody	366M-98	FDA UDI	Class I	Active
A-1-Antitrypsin Rabbit Polyclonal Antibody	223A-17	FDA UDI	Class I	Active
ROS1 (MRQ-68) Rabbit Monoclonal Antibody	469R-97-ASR	FDA UDI	Class I	Unknown
Inhibin, alpha (R1) Mouse Monoclonal Antibody	271M-16	FDA UDI	Class I	Active
A-1-Antitrypsin Rabbit Polyclonal Antibody	223A-14	FDA UDI	Class I	Active
MART-1 (Melan A) (M2-7C10) Mouse Monoclonal Antibody	281M-96	FDA UDI	Class I	Active
PMS2 (MRQ-28) Mouse Monoclonal Antibody	288M-16-ASR	FDA UDI	Class I	Active
Herpes Simplex Virus I (10A3) Mouse Monoclonal Antibody	361M-14-ASR	FDA UDI	Class I	Active
p120 Catenin (MRQ-5) Mouse Monoclonal Antibody	420M-14	FDA UDI	Class I	Active
p53 (EP9) Rabbit Monoclonal Primary Antibody	453R-24	FDA UDI	Class I	Active
GH Rabbit Polyclonal Antibody	208A-76	FDA UDI	Class I	Active
Uroplakin II (MRQ-71) Rabbit Monoclonal Antibody	491R-94	FDA UDI	Class I	Active
MDM2 (IF2) Mouse Monoclonal Antibody	479M-98	FDA UDI	Class I	Unknown
Calretinin (SP13) Rabbit Monoclonal Antibody	232R-16	FDA UDI	Class I	Active
Cytokeratin 19 (EP72) Rabbit Monoclonal Primary Antibody	319R-26	FDA UDI	Class I	Active
BCL2 (124) Mouse Monoclonal Antibody	226M-90	FDA UDI	Class I	Active
p40 (ZR8) Rabbit Monoclonal Antibody	483R-14	FDA UDI	Class I	Active
Ep-CAM/Epithelial Specific Antigen (MOC-31) Mouse Monoclonal Antibody	248M-14	FDA UDI	Class I	Active
Thrombomodulin (1009) Mouse Monoclonal Antibody	339M-14	FDA UDI	Class I	Active
STAT6 (EP325) Rabbit Monoclonal Primary Antibody	426R-18	FDA UDI	Class I	Active
Olig2 (211F1.1) Mouse Monoclonal Antibody	387M-18	FDA UDI	Class I	Active
CD34 (EP88) Rabbit Monoclonal Primary Antibody	134R-18	FDA UDI	Class I	Active
Lysozyme Rabbit Polyclonal Antibody	278A-18	FDA UDI	Class I	Active
CMV (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Antibody	213M-25-ASR	FDA UDI	Class I	Active
Inhibin, alpha (R1) Mouse Monoclonal Antibody	271M-17	FDA UDI	Class I	Active
L1 (Cytoactiv) Mouse Monoclonal Antibody	498M-18-ASR	FDA UDI	Class I	Active
Collagen Type IV (CIV22) Mouse Monoclonal Antibody	239M-16	FDA UDI	Class I	Active
Cytokeratin (34betaE12) Mouse Monoclonal Antibody	334M-85	FDA UDI	Class I	Active
Melanoma Associated Antigen (KBA.62) Mouse Monclonal Antibody	760-4527	FDA UDI	Class I	Active
CD23 (SP23) Rabbit Monoclonal Antibody	123R-17	FDA UDI	Class I	Active
A-1-Antichymotrypsin Rabbit Polyclonal Antibody	760-2604	FDA UDI	Class I	Active
TSH Rabbit Polyclonal Antibody	211A-18	FDA UDI	Class I	Active
CD138 (EP201) Rabbit Monoclonal Primary Antibody	138R-28	FDA UDI	Class I	Active
CD23 (1B12) Mouse Monoclonal Antibody	123M-14	FDA UDI	Class I	Active
CD8 (C8/144B) Mouse Monoclonal Antibody	108M-95	FDA UDI	Class I	Active
TdT (EP266) Rabbit Monoclonal Primary Antibody	338R-25	FDA UDI	Class I	Active
Islet-1 (EP283) Rabbit Monoclonal Primary Antibody	431R-18	FDA UDI	Class I	Active
Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody	340M-17	FDA UDI	Class I	Active
Helicobacter pylori Rabbit Polyclonal Antibody	215A-74-ASR	FDA UDI	Class I	Active
Peripherin (8G2) Mouse Monoclonal Antibody	476M-16	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.