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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 27 of 44

Device	Model / Reference	Registries	Class	Status
Cytokeratin (35betaH11) Mouse Monoclonal Antibody	335M-95	FDA UDI	Class I	Active
Her2/Neu (SP3) Rabbit Monoclonal Antibody	237R-15-ASR	FDA UDI	Class I	Active
BCL6 (EP278) Rabbit Monoclonal Primary Antibody	227R-27	FDA UDI	Class I	Active
GLUT1 Rabbit Polyclonal Antibody	355A-18	FDA UDI	Class I	Active
MUC6 (MRQ-20) Mouse Monoclonal Antibody	760-4390	FDA UDI	Class I	Active
S100 beta (EP32) Rabbit Monoclonal Primary Antibody	449R-18	FDA UDI	Class I	Active
MUM1 (MRQ-8) Mouse Monoclonal Antibody	358M-17	FDA UDI	Class I	Active
PD-L1 (28-8) Rabbit Monoclonal Primary Antibody	438R-16-ASR	FDA UDI	Class I	Active
Cytokeratin 5 (EP1601Y) Rabbit Monoclonal Primary Antibody	305R-18	FDA UDI	Class I	Active
S100P (16/f5) Mouse Monoclonal Antibody	376M-98	FDA UDI	Class I	Active
Oct-4 (MRQ-10) Mouse Monoclonal Antibody	760-4392	EUDAMEDFDA UDI	Class I	Active
CD4 (EP204) Rabbit Monoclonal Primary Antibody	104R-26	FDA UDI	Class I	Active
PD-L1 (ZR3) Rabbit Monoclonal Antibody	438R-28-ASR	FDA UDI	Class I	Active
Cathepsin K (3F9) Mouse Monoclonal Antibody	402M-14	FDA UDI	Class I	Active
p16INK4A (JC2) Mouse Monoclonal Antibody	416M-15-ASR	FDA UDI	Class I	Active
PD-1 (NAT105) Mouse Monoclonal Antibody	315M-98	FDA UDI	Class I	Active
CD7 (MRQ-56) Mouse Monoclonal Antibody	107M-24	FDA UDI	Class I	Active
CD13 (SP187) Rabbit Monoclonal Antibody	113R-17	FDA UDI	Class I	Active
C3d Rabbit Polyclonal Antibody	403A-75	FDA UDI	Class I	Active
p40 (ZR8) Rabbit Monoclonal Antibody	483R-10	FDA UDI	Class I	Active
Olig2 (EP112) Rabbit Monoclonal Primary Antibody	387R-16	FDA UDI	Class I	Active
Galectin-3 (9C4) Mouse Monoclonal Antibody	255M-17	FDA UDI	Class I	Active
MyoD1 (EP212) Rabbit Monoclonal Primary Antibody	386R-18	FDA UDI	Class I	Active
Parathyroid Hormone (PTH) (MRQ-31) Mouse Monoclonal Antibody	310M-24	FDA UDI	Class I	Active
hCG Rabbit Polyclonal Antibody	234A-16	FDA UDI	Class I	Active
Factor VIII-R Ag. Rabbit Polyclonal Antibody	250A-15	FDA UDI	Class I	Active
Synaptophysin (EP158) Rabbit Monoclonal Primary Antibody	336R-18	FDA UDI	Class I	Active
Ki-67 (MRQ-64) Rabbit Monoclonal Antibody	275R-35	FDA UDI	Class I	Unknown
HGAL (MRQ-49) Mouse Monoclonal Antibody	760-4597	FDA UDI	Class I	Active
Herpes Simplex Virus I Rabbit Polyclonal Antibody	361A-16-ASR	FDA UDI	Class I	Active
Spectrin (RBC2/3D5) Mouse Monoclonal Antibody	333M-16	FDA UDI	Class I	Active
Hemoglobin A (EPR3608) Rabbit Monoclonal Primary Antibody	360R-18	FDA UDI	Class I	Active
p53 (DO7) Mouse Monoclonal Antibody	453M-97	FDA UDI	Class I	Active
Helicobacter pylori Rabbit Polyclonal Antibody	215A-76-ASR	FDA UDI	Class I	Active
PAX-5 (SP34) Rabbit Monoclonal Antibody	312R-14	FDA UDI	Class I	Active
Factor XIIIa (EP3372) Rabbit Monoclonal Primary Antibody	251R-14	FDA UDI	Class I	Active
MLH1 (G168-728) Mouse Monoclonal Antibody	285M-18-ASR	FDA UDI	Class I	Active
LEF1 (EP310) Rabbit Monoclonal Primary Antibody	442R-15	EUDAMEDFDA UDI	Class I	Active
Glycophorin A (GA-R2) Mouse Monoclonal Antibody	260M-16	FDA UDI	Class I	Active
Inhibin, alpha (R1) Mouse Monoclonal Antibody	271M-14	FDA UDI	Class I	Active
Her2/Neu (SP3) Rabbit Monoclonal Antibody	237R-17-ASR	FDA UDI	Class I	Active
HGAL (MRQ-49) Mouse Monoclonal Antibody	375M-98	FDA UDI	Class I	Active
TLE1 (1F5) Mouse Monoclonal Antibody	401M-18	FDA UDI	Class I	Active
Kappa (L1C1) Mouse Monoclonal Antibody	274M-95	FDA UDI	Class I	Active
CD56 (123C3.D5) Mouse Monoclonal Antibody	156M-86	FDA UDI	Class I	Active
MART-1 (Melan A) (M2-7C10) Mouse Monoclonal Antibody	281M-95	FDA UDI	Class I	Active
SV40 (MRQ-4) Mouse Monoclonal Antibody	351M-18-ASR	FDA UDI	Class I	Active
MSH6 (SP93) Rabbit Monoclonal Antibody	287R-28-ASR	FDA UDI	Class I	Active
Human Placental Lactogen (hPL) Rabbit Polyclonal Antibody	266A-15	FDA UDI	Class I	Active
CD34 (QBEnd/10) Mouse Monoclonal Antibody	760-2620	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.