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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 30 of 44

Device	Model / Reference	Registries	Class	Status
p53 (DO7) Mouse Monoclonal Antibody	453M-98	FDA UDI	Class I	Active
ERG (EP111) Rabbit Monoclonal Primary Antibody	434R-17	FDA UDI	Class I	Active
MUC4 (8G7) Mouse Monoclonal Antibody	406M-17	FDA UDI	Class I	Active
Cytokeratin 14 (SP53) Rabbit Monoclonal Antibody	314R-15	FDA UDI	Class I	Active
MUC5AC (MRQ-19) Mouse Monoclonal Antibody	292M-98	FDA UDI	Class I	Active
TSH (EP254) Rabbit Monoclonal Primary Antibody	211R-17	FDA UDI	Class I	Active
Cytokeratin (35betaH11) Mouse Monoclonal Antibody	760-2637	FDA UDI	Class I	Active
Galectin-3 (9C4) Mouse Monoclonal Antibody	255M-14	FDA UDI	Class I	Active
A-1-Antichymotrypsin Rabbit Polyclonal Antibody	222A-16	FDA UDI	Class I	Active
CD68 (Kp-1) Mouse Monoclonal Antibody	168M-94	FDA UDI	Class I	Active
Villin (CWWB1) Mouse Monoclonal Antibody	346M-17	FDA UDI	Class I	Active
Vimentin (EP21) Rabbit Monoclonal Primary Antibody	347R-26	FDA UDI	Class I	Active
Cytokeratin, HMW (AE3) Mouse Monoclonal Antibody	303M-14	FDA UDI	Class I	Active
Hepatitis B Virus Core Antigen Rabbit Polyclonal Antibody	216A-17-ASR	FDA UDI	Class I	Active
GH (EP267) Rabbit Monoclonal Primary Antibody	208R-17	FDA UDI	Class I	Active
CD16 (SP175) Rabbit Monoclonal Antibody	116R-18	FDA UDI	Class I	Active
CD21 (EP3093) Rabbit Monoclonal Primary Antibody	121R-17	FDA UDI	Class I	Active
CD5 (SP19) Rabbit Monoclonal Antibody	205R-16	FDA UDI	Class I	Active
CD5 (EP77) Rabbit Monoclonal Primary Antibody	205R-28	FDA UDI	Class I	Active
Parathyroid Hormone (PTH) (MRQ-31) Mouse Monoclonal Antibody	310M-25	FDA UDI	Class I	Active
CD16 (SP175) Rabbit Monoclonal Primary Antibody	760-4863	FDA UDI	Class I	Active
Estrogen Receptor (EP1) Rabbit Monoclonal Primary Antibody	249R-24-ASR	FDA UDI	Class I	Active
CD103 (EP206) Rabbit Monoclonal Primary Antibody	437R-18	FDA UDI	Class I	Active
INI-1 (MRQ-27) Mouse Monoclonal Antibody	272M-18	FDA UDI	Class I	Active
S-100 (4C4.9) Mouse Monoclonal Antibody	330M-15	FDA UDI	Class I	Active
CD8 (C8/144B) Mouse Monoclonal Antibody	108M-96	FDA UDI	Class I	Active
CD2 (EP222) Rabbit Monoclonal Primary Antibody	102R-14	FDA UDI	Class I	Active
Epstein-Barr Virus (MRQ-47) Rabbit Monoclonal Antibody	245R-15-ASR	FDA UDI	Class I	Active
Cytokeratin 14 (LL002) Mouse Monoclonal Antibody	314M-16	FDA UDI	Class I	Active
p40 (ZR8) Rabbit Monoclonal Antibody	483R-18	FDA UDI	Class I	Active
Mesothelin (EP140) Rabbit Monoclonal Primary Antibody	439R-15	FDA UDI	Class I	Active
CD2 (EP222) Rabbit Monoclonal Primary Antibody	102R-18	FDA UDI	Class I	Active
Cytokeratin 19 (EP72) Rabbit Monoclonal Primary Antibody	319R-27	FDA UDI	Class I	Active
SOX-10 Rabbit Polyclonal Antibody	383A-75	FDA UDI	Class I	Active
HHV-8 (13B10) Mouse Monoclonal Antibody	265M-17-ASR	FDA UDI	Class I	Active
Glutamine Synthetase (GS-6) Mouse Monoclonal Antibody	389M-16	FDA UDI	Class I	Active
Cytokeratin 5 (SP27) Rabbit Monoclonal Primary Antibody	760-4935	EUDAMEDFDA UDI	Class I	Active
GLUT3 Rabbit Polyclonal Antibody	413A-18	FDA UDI	Class I	Active
PAX-7 (MRQ-69) Mouse Monoclonal Antibody	481M-95	FDA UDI	Class I	Unknown
Peripherin (8G2) Mouse Monoclonal Antibody	476M-14	FDA UDI	Class I	Active
Lysozyme Rabbit Polyclonal Antibody	760-2656	FDA UDI	Class I	Active
C4d (SP91) Rabbit Monoclonal Antibody	404R-14	FDA UDI	Class I	Active
Inhibin, alpha (R1) Mouse Monoclonal Antibody	271M-18	FDA UDI	Class I	Active
Prolactin Rabbit Polyclonal Antibody	760-2803	FDA UDI	Class I	Active
SOX-2 (SP76) Rabbit Monoclonal Antibody	371R-14	FDA UDI	Class I	Active
Desmin (D33) Mouse Monoclonal Antibody	243M-15	FDA UDI	Class I	Active
Chromogranin A (LK2H10) Mouse Monoclonal Antibody	238M-98	FDA UDI	Class I	Active
Carbonic Anhydrase IX (CA IX) (MRQ-54) Mouse Monoclonal Antibody	379M-15	FDA UDI	Class I	Active
PHOX2B (EP312) Rabbit Monoclonal Primary Antibody	422R-17	FDA UDI	Class I	Active
Helicobacter pylori Rabbit Polyclonal Antibody	215A-78-ASR	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.