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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 5 of 44

Device	Model / Reference	Registries	Class	Status
p21WAF1 (DCS-60.2) Mouse Monoclonal Antibody	421M-16	FDA UDI	Class I	Active
h-Caldesmon (hHCD) Mouse Monoclonal Antibody	451M-18	FDA UDI	Class I	Active
CD7 (EP132) Rabbit Monoclonal Primary Antibody	107R-17	FDA UDI	Class I	Active
Uroplakin II (MRQ-71) Rabbit Monoclonal Antibody	491R-96	FDA UDI	Class I	Active
CD14 (EPR3653) Rabbit Monoclonal Antibody	760-4523	FDA UDI	Class I	Active
Nerve Growth Factor Receptor (NGFR) (MRQ-21) Mouse Monoclonal Antibody	304M-14	FDA UDI	Class I	Active
IgA (EP170) Rabbit Monoclonal Primary Antibody	267R-15	FDA UDI	Class I	Active
NSE (MRQ-55) Mouse Monoclonal Antibody	306M-26	FDA UDI	Class I	Active
Hepatocyte Specific Antigen (Hep-Par1) (EP265) Rabbit Monoclonal Primary Antibod	264R-16	FDA UDI	Class I	Active
Somatostatin (EP130) Rabbit Monoclonal Primary Antibody	332R-17	FDA UDI	Class I	Active
Ksp-cadherin (MRQ-33) Mouse Monoclonal Antibody	276M-94	FDA UDI	Class I	Active
CD13 (SP187) Rabbit Monoclonal Primary Antibody	760-4862	FDA UDI	Class I	Active
Villin (CWWB1) Mouse Monoclonal Antibody	346M-14	FDA UDI	Class I	Active
BCL2 (SP66) Rabbit Monoclonal Antibody	226R-27	FDA UDI	Class I	Active
ACTH Rabbit Polyclonal Antibody	206A-77	FDA UDI	Class I	Active
CD19 (EP169) Rabbit Monoclonal Primary Antibody	119R-17	FDA UDI	Class I	Active
TAG-72 (B72.3) Mouse Monoclonal Antibody	337M-85	FDA UDI	Class I	Active
PAX-5 (EP156) Rabbit Monoclonal Primary Antibody	312R-28	FDA UDI	Class I	Active
MSH2 (G219-1129) Mouse Monoclonal Antibody	286M-17-ASR	FDA UDI	Class I	Active
GCDFP-15 (23A3) Mouse Monoclonal Antibody	257M-10	FDA UDI	Class I	Active
h-Caldesmon (hHCD) Mouse Monoclonal Antibody	451M-15	FDA UDI	Class I	Active
Macrophage (HAM-56) Mouse Monoclonal Antibody	760-2657	FDA UDI	Class I	Active
CD68 (Kp-1) Mouse Monoclonal Antibody	168M-98	FDA UDI	Class I	Active
Cytokeratin (35betaH11) Mouse Monoclonal Antibody	335M-94	FDA UDI	Class I	Active
Cytokeratin 5 & 6 (D5 & 16B4) Mouse Monoclonal Antibody	356M-16	FDA UDI	Class I	Active
Her2/Neu (EP3) Rabbit Monoclonal Primary Antibody	237R-27-ASR	FDA UDI	Class I	Active
BG8, LewisY (F3) Mouse Monoclonal Antibody	228M-18	FDA UDI	Class I	Active
CDK4 (DCS-31) Mouse Monoclonal Antibody	478M-95	FDA UDI	Class I	Unknown
BG8, LewisY (F3) Mouse Monoclonal Antibody	228M-17	FDA UDI	Class I	Active
Parvovirus B19 (R92F6) Mouse Monoclonal Antibody	218M-16-ASR	FDA UDI	Class I	Active
Adenovirus (20/11 & 2/6) Mouse Monoclonal Antibody	212M-15-ASR	FDA UDI	Class I	Active
GH (EP267) Rabbit Monoclonal Primary Antibody	208R-14	FDA UDI	Class I	Active
LMO2 (SP51) Rabbit Monoclonal Antibody	370R-16	FDA UDI	Class I	Active
Herpes Simplex Virus I Rabbit Polyclonal Antibody	361A-14-ASR	FDA UDI	Class I	Active
FoxP1 (SP133) Rabbit Monoclonal Antibody	350R-14	FDA UDI	Class I	Active
PAX-2 (EP235) Rabbit Monoclonal Primary Antibody	311R-15	FDA UDI	Class I	Active
H3 K27M (RM192) Rabbit Monoclonal Antibody	492R-18	FDA UDI	Class I	Active
CD4 (SP35) Rabbit Monoclonal Antibody	104R-16	FDA UDI	Class I	Active
ROS1 (MRQ-68) Rabbit Monoclonal Antibody	469R-98	FDA UDI	Class I	Unknown
Glutamine Synthetase (GS-6) Mouse Monoclonal Primary Antibody	760-4898	FDA UDI	Class I	Active
TdT Rabbit Polyclonal Antibody	760-2670	FDA UDI	Class I	Active
Inhibin, alpha (MRQ-63) Rabbit Monoclonal Antibody	271R-25	FDA UDI	Class I	Active
Calretinin Rabbit Polyclonal Antibody	232A-74	FDA UDI	Class I	Active
SALL4 (EP299) Rabbit Monoclonal Primary Antibody	385R-16	FDA UDI	Class I	Active
Herpes Simplex Virus II Rabbit Polyclonal Antibody	362A-76-ASR	FDA UDI	Class I	Active
Annexin A1 (MRQ-3) Mouse Monoclonal Antibody	221M-15	FDA UDI	Class I	Active
Calcitonin (SP17) Rabbit Monoclonal Antibody	229R-15	FDA UDI	Class I	Active
Synaptophysin (EP158) Rabbit Monoclonal Primary Antibody	336R-15	FDA UDI	Class I	Active
CD5 (4C7) Mouse Monoclonal Antibody	205M-16	FDA UDI	Class I	Active
Parathyroid Hormone (PTH) (MRQ-31) Mouse Monoclonal Antibody	310M-28	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.