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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 24 of 44

Device	Model / Reference	Registries	Class	Status
PHOX2B (EP312) Rabbit Monoclonal Primary Antibody	422R-18	FDA UDI	Class I	Active
SOX-10 Rabbit Polyclonal Antibody	383A-74	FDA UDI	Class I	Active
p21/WAF1 (DCS-60.2) Mouse Monoclonal Antibody	760-4453	FDA UDI	Class I	Active
Factor XIIIa (EP3372) Rabbit Monoclonal Primary Antibody	251R-15	FDA UDI	Class I	Active
Ksp-cadherin (MRQ-33) Mouse Monoclonal Antibody	276M-98	FDA UDI	Class I	Active
Progesterone Receptor (Y85) Rabbit Monoclonal Primary Antibody	323R-18-ASR	FDA UDI	Class I	Active
Tyrosinase (T311) Mouse Monoclonal Antibody	344M-96	FDA UDI	Class I	Active
Oct-2 (MRQ-2) Mouse Monoclonal Antibody	308M-18	FDA UDI	Class I	Active
Renal Cell Carcinoma (PN-15) Mouse Monoclonal Antibody	329M-96	FDA UDI	Class I	Active
CD14 (EPR3653) Rabbit Monoclonal Primary Antibody	114R-17	FDA UDI	Class I	Active
Glucagon Rabbit Polyclonal Antibody	259A-14	FDA UDI	Class I	Active
PAX-5 (24) Mouse Monoclonal Antibody	312M-18	FDA UDI	Class I	Active
TFE3 (MRQ-37) Rabbit Monoclonal Primary Antibody	760-4622	EUDAMEDFDA UDI	Class I	Active
Cytokeratin 5 (EP1601Y) Rabbit Monoclonal Primary Antibody	305R-15	FDA UDI	Class I	Active
FSH Rabbit Polyclonal Antibody	207A-78	FDA UDI	Class I	Active
FSH (EP257) Rabbit Monoclonal Primary Antibody	207R-18	FDA UDI	Class I	Active
Treponema pallidum Rabbit Polyclonal Antibody	397A-16-ASR	FDA UDI	Class I	Active
Myoglobin Rabbit Polyclonal Antibody	760-2660	FDA UDI	Class I	Active
Carbonic Anhydrase IX (CA IX)(MRQ-54) Mouse Monoclonal Antibody	379M-18	FDA UDI	Class I	Active
CD79a (SP18) Rabbit Monoclonal Antibody	179R-14	FDA UDI	Class I	Active
Tyrosinase (T311) Mouse Monoclonal Antibody	344M-97	FDA UDI	Class I	Active
PLAP (NB10) Mouse Monoclonal Antibody	321M-14	FDA UDI	Class I	Active
PU.1 (EPR3158Y) Rabbit Monoclonal Primary Antibody	328R-18	FDA UDI	Class I	Active
BG8, Lewis Y (F3) Mouse Monoclonal Antibody	760-4450	FDA UDI	Class I	Active
Spectrin (RBC2/3D5) Mouse Monoclonal Antibody	333M-14	FDA UDI	Class I	Active
Desmin (EP15) Rabbit Monoclonal Primary Antibody	243R-17	FDA UDI	Class I	Active
Calretinin (SP13) Rabbit Monoclonal Antibody	232R-15	FDA UDI	Class I	Active
TCL1 (MRQ-7) Mouse Monoclonal Antibody	357M-17	FDA UDI	Class I	Active
Estrogen Receptor (SP1) Rabbit Monoclonal Antibody	249R-14-ASR	FDA UDI	Class I	Active
CD31 (EP78) Rabbit Monoclonal Primary Antibody	131R-26	FDA UDI	Class I	Active
PU.1 (EPR3158Y) Rabbit Monoclonal Primary Antibody	328R-17	FDA UDI	Class I	Active
Heat Shock Protein 70 (EP377) Rabbit Monoclonal Primary Antibody	460R-16	FDA UDI	Class I	Active
p40 (ZR8) Rabbit Monoclonal Antibody	483R-17	FDA UDI	Class I	Active
Adipophilin Rabbit Polyclonal Antibody	393A-14	FDA UDI	Class I	Active
MUC5AC (MRQ-19) Mouse Monoclonal Antibody	760-4389	FDA UDI	Class I	Active
anti-NSE (MRQ-55) Mouse Monoclonal Primary Antibody	760-4786	FDA UDI	Class I	Active
Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody	251M-17	FDA UDI	Class I	Active
BCL2 (E17) Rabbit Monoclonal Primary Antibody	226R-17	FDA UDI	Class I	Active
Cytokeratin 14 (LL002) Mouse Monoclonal Antibody	314M-17	FDA UDI	Class I	Active
SALL4 (EP299) Rabbit Monoclonal Primary Antibody	385R-14	FDA UDI	Class I	Active
S100A1 (EP184) Rabbit Monoclonal Primary Antibody	408R-14	FDA UDI	Class I	Active
Desmin (D33) Mouse Monoclonal Antibody	243M-16	FDA UDI	Class I	Active
CD13 (EP117) Rabbit Monoclonal Primary Antibody	113R-24	FDA UDI	Class I	Active
CD79a (JCB117) Mouse Monoclonal Antibody	179M-97	FDA UDI	Class I	Active
CD71 (EP232) Rabbit Monoclonal Primary Antibody	171R-17	FDA UDI	Class I	Active
Napsin A (EP205) Rabbit Monoclonal Primary Antibody	352R-15	FDA UDI	Class I	Active
TSH (EP254) Rabbit Monoclonal Primary Antibody	211R-14	FDA UDI	Class I	Active
IgD (EP173) Rabbit Monoclonal Primary Antibody	268R-15	FDA UDI	Class I	Active
MSH6 (44) Mouse Monoclonal Antibody	287M-18-ASR	FDA UDI	Class I	Active
CD2 (EP222) Rabbit Monoclonal Primary Antibody	102R-15	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.