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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 11 of 44

Device	Model / Reference	Registries	Class	Status
Myeloperoxidase Rabbit Polyclonal Antibody	289A-76	FDA UDI	Class I	Active
PD-1 (EP239) Rabbit Monoclonal Primary Antibody	315R-18	FDA UDI	Class I	Active
Cytokeratin, HMW (AE3) Mouse Monoclonal Antibody	303M-17	FDA UDI	Class I	Active
T-bet (MRQ-46) Rabbit Monoclonal Antibody	368R-78	FDA UDI	Class I	Active
Epstein-Barr Virus (MRQ-47) Rabbit Monoclonal Antibody	245R-16	FDA UDI	Class I	Unknown
Collagen Type IV (CIV22) Mouse Monoclonal Antibody	239M-14	FDA UDI	Class I	Active
PAX-5 (SP34) Rabbit Monoclonal Antibody	312R-15	FDA UDI	Class I	Active
CD5 (EP77) Rabbit Monoclonal Primary Antibody	205R-24	FDA UDI	Class I	Active
MUC2 (MRQ-18) Mouse Monoclonal Antibody	291M-16	FDA UDI	Class I	Active
Granzyme B Rabbit Polyclonal Antibody	262A-14	FDA UDI	Class I	Active
PSMA (EP192) Rabbit Monoclonal Primary Antibody	327R-18	FDA UDI	Class I	Active
CD33 (PWS44) Mouse Monoclonal Antibody	133M-15	FDA UDI	Class I	Active
CD79a (JCB117) Mouse Monoclonal Antibody	179M-96	FDA UDI	Class I	Active
PD-1 (NAT105) Mouse Monoclonal Antibody	315M-95	FDA UDI	Class I	Active
p53 (DO7) Mouse Monoclonal Antibody	453M-96	FDA UDI	Class I	Active
PSA (ER-PR8) Mouse Monoclonal Antibody	324M-17	FDA UDI	Class I	Active
CD5 (4C7) Mouse Monoclonal Antibody	205M-17	FDA UDI	Class I	Active
CD23 (SP23) Rabbit Monoclonal Antibody	123R-15	FDA UDI	Class I	Active
Cytokeratin 7 (OV-TL 12/30) Mouse Monoclonal Antibody	307M-97	FDA UDI	Class I	Active
CD61 (EP65) Rabbit Monoclonal Primary Antibody	161R-17	FDA UDI	Class I	Active
SOX-2 (EP103) Rabbit Monoclonal Primary Antibody	371R-24	FDA UDI	Class I	Active
CD23 (1B12) Mouse Monoclonal Antibody	123M-15	FDA UDI	Class I	Active
CDK4 (DCS-31) Mouse Monoclonal Antibody	478M-94	FDA UDI	Class I	Unknown
CD3 (MRQ-39) Rabbit Monoclonal Antibody	103R-98	FDA UDI	Class I	Active
Cytokeratin (34betaE12) Mouse Monoclonal Antibody	334M-86	FDA UDI	Class I	Active
Claudin 1 Rabbit Polyclonal Antibody	359A-14	FDA UDI	Class I	Active
hCG Rabbit Polyclonal Antibody	234A-17	FDA UDI	Class I	Active
CD38 (SP149) Rabbit Monoclonal Antibody	118R-16	FDA UDI	Class I	Active
Carbonic Anhydrase IX (CA IX) (EP161) Rabbit Monoclonal Primary Antibody	379R-17	FDA UDI	Class I	Active
CD79a (SP18) Rabbit Monoclonal Antibody	179R-17	FDA UDI	Class I	Active
PSA (EP109) Rabbit Monoclonal Primary Antibody	324R-18	FDA UDI	Class I	Active
PAX-8 (SP348) Rabbit Monoclonal Antibody	363R-30	FDA UDI	Class I	Active
h-Caldesmon (hHCD) Mouse Monoclonal Antibody	451M-16	FDA UDI	Class I	Active
Langerin (12D6) Mouse Monoclonal Antibody	392M-18	FDA UDI	Class I	Active
CD103 (EP206) Rabbit Monoclonal Primary Antibody	437R-16	FDA UDI	Class I	Active
Cytokeratin, HMW (AE3) Mouse Monoclonal Antibody	303M-16	FDA UDI	Class I	Active
CD123 (6H6) Mouse Monoclonal Antibody	198M-18	FDA UDI	Class I	Active
MLH1 (G168-728) Mouse Monoclonal Antibody	285M-15	FDA UDI	Class I	Unknown
CD13 (SP187) Rabbit Monoclonal Antibody	113R-16	FDA UDI	Class I	Active
NUTM1 (C52B1) Rabbit Monoclonal Antibody	494R-18	FDA UDI	Class I	Active
Kappa (L1C1) Mouse Monoclonal Antibody	274M-97	FDA UDI	Class I	Active
CD34 (EP88) Rabbit Monoclonal Primary Antibody	134R-17	FDA UDI	Class I	Active
MUC1 (EP85) Rabbit Monoclonal Primary Antibody	290R-16	FDA UDI	Class I	Active
Granzyme B Rabbit Polyclonal Antibody	262A-15	FDA UDI	Class I	Active
TRAcP (9C5) Mouse Monoclonal Antibody	341M-97	FDA UDI	Class I	Active
Prolactin Rabbit Polyclonal Antibody	210A-17	FDA UDI	Class I	Active
MSH6 (44) Mouse Monoclonal Antibody	287M-15	FDA UDI	Class I	Unknown
Cytokeratin 5 & 6 (D5 & 16B4) Mouse Monoclonal Antibody	356M-14	FDA UDI	Class I	Active
NSE (MRQ-55) Mouse Monoclonal Antibody	306M-27	FDA UDI	Class I	Active
CD31 (EP78) Rabbit Monoclonal Primary Antibody	131R-24	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.