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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 16 of 44

Device	Model / Reference	Registries	Class	Status
p57/Kip2 (Kp10) Mouse Monoclonal Antibody	457M-96	FDA UDI	Class I	Active
BCA-225 (Cu-18) Mouse Monoclonal Antibody	225M-15	FDA UDI	Class I	Active
Hepatitis B Virus Core Antigen Rabbit Polyclonal Antibody	216A-15-ASR	FDA UDI	Class I	Active
Her2/Neu (EP3) Rabbit Monoclonal Primary Antibody	237R-25-ASR	FDA UDI	Class I	Active
Cytokeratin, LMW (AE1) Mouse Monoclonal Antibody	301M-16	FDA UDI	Class I	Active
IgG4 (MRQ-44) Mouse Monoclonal Antibody	367M-18	EUDAMEDFDA UDI	Class I	Active
CD79a (JCB117) Mouse Monoclonal Antibody	179M-95	FDA UDI	Class I	Active
CD33 (PWS44) Mouse Monoclonal Antibody	133M-14	FDA UDI	Class I	Active
Hepatocyte Specific Antigen (Hep-Par1) (EP265) Rabbit Monoclonal Primary Antibod	264R-18	FDA UDI	Class I	Active
Gastrin Rabbit Polyclonal Antibody	256A-16	FDA UDI	Class I	Active
CD15 (MMA) Mouse Monoclonal Antibody	115M-14	FDA UDI	Class I	Active
Her2/Neu (EP3) Rabbit Monoclonal Primary Antibody	237R-20-ASR	FDA UDI	Class I	Active
FOXP1 (EP137) Rabbit Monoclonal Primary Antibody	350R-24	FDA UDI	Class I	Active
COX-2 (SP21) Rabbit Monoclonal Antibody	240R-16	FDA UDI	Class I	Active
Herpes Simplex Virus II (3C5.2) Mouse Monoclonal Antibody	362M-18-ASR	FDA UDI	Class I	Active
p16INK4A (JC2) Mouse Monoclonal Antibody	416M-14-ASR	FDA UDI	Class I	Active
GLUT1 Rabbit Polyclonal Antibody	760-4526	FDA UDI	Class I	Active
Granzyme B (EP230) Rabbit Monoclonal Primary Antibody	262R-16	FDA UDI	Class I	Active
Epstein-Barr Virus (CS1-4) Mouse Monoclonal Antibody	245M-14-ASR	FDA UDI	Class I	Active
hCG Rabbit Polyclonal Antibody	234A-15	FDA UDI	Class I	Active
MUC5AC (MRQ-19) Mouse Monoclonal Antibody	292M-96	FDA UDI	Class I	Active
NSE (MRQ-55) Mouse Monoclonal Antibody	306M-24	FDA UDI	Class I	Active
Pneumocystis jiroveci (carinii) (3F6) Mouse Monoclonal Antibody	219M-14-ASR	FDA UDI	Class I	Active
MUC1 (MRQ-17) Mouse Monoclonal Antibody	290M-14	FDA UDI	Class I	Active
Vimentin (V9) Mouse Monoclonal Antibody	347M-17	FDA UDI	Class I	Active
Cytokeratin (35betaH11) Mouse Monoclonal Antibody	335M-96	FDA UDI	Class I	Active
T-bet (MRQ-46) Rabbit Monoclonal Antibody	368R-77	FDA UDI	Class I	Active
Chromogranin A (LK2H10) Mouse Monoclonal Antibody	238M-96	FDA UDI	Class I	Active
Uroplakin III (SP73) Rabbit Monoclonal Antibody	345R-17	FDA UDI	Class I	Active
CD99 (EPR3097Y) Rabbit Monoclonal Primary Antibody	199R-16	FDA UDI	Class I	Active
Cytokeratin 20 (Ks20.8) Mouse Monoclonal Antibody	320M-18	FDA UDI	Class I	Active
CD2 (MRQ-11) Mouse Monoclonal Antibody	102M-15	FDA UDI	Class I	Active
Myeloperoxidase (EP151) Rabbit Monoclonal Primary Antibody	289R-27	FDA UDI	Class I	Active
Her2/Neu (EP3) Rabbit Monoclonal PrimaryAntibody	237R-28-ASR	FDA UDI	Class I	Active
Glycophorin A (GA-R2) Mouse Monoclonal Antibody	260M-18	FDA UDI	Class I	Active
PSMA (EP192) Rabbit Monoclonal Primary Antibody	327R-16	FDA UDI	Class I	Active
KBA.62 (KBA.62) Mouse Monoclonal Antibody	366M-96	FDA UDI	Class I	Active
Progesterone Receptor (SP42) Rabbit Monoclonal Antibody	323R-35-ASR	FDA UDI	Class I	Active
Cytokeratin 20 (Ks20.8) Mouse Monoclonal Antibody	320M-17	FDA UDI	Class I	Active
GLUT3 Rabbit Polyclonal Antibody	413A-16	FDA UDI	Class I	Active
Myogenin (F5D) Mouse Monoclonal Antibody	296M-17	FDA UDI	Class I	Active
Glutamine Synthetase (GS-6) Mouse Monoclonal Antibody	389M-15	FDA UDI	Class I	Active
CD63 (NKI/C3) Mouse Monoclonal Antibody	263M-14	FDA UDI	Class I	Active
Vimentin (EP21) Rabbit Monoclonal Primary Antibody	347R-24	FDA UDI	Class I	Active
Kappa (L1C1) Mouse Monoclonal Antibody	274M-98	FDA UDI	Class I	Active
p63 (EP174) Rabbit Monoclonal Primary Antibody	482R-14	FDA UDI	Class I	Active
PSA (EP109) Rabbit Monoclonal Primary Antibody	324R-15	FDA UDI	Class I	Active
CITED1 (5H6) Mouse Monoclonal Antibody	424M-17	FDA UDI	Class I	Active
CD13 (SP187) Rabbit Monoclonal Antibody	113R-18	FDA UDI	Class I	Active
MUM1 (MRQ-43) Rabbit Monoclonal Antibody	760-4529	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.