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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 31 of 44

Device	Model / Reference	Registries	Class	Status
TFE3 (MRQ-37) Rabbit Monoclonal Antibody	354R-18	FDA UDI	Class I	Active
CD56 (123C3.D5) Mouse Monoclonal Antibody	156M-87	FDA UDI	Class I	Active
CD25 (4C9) Mouse Monoclonal Antibody	125M-15	FDA UDI	Class I	Active
EGFR (EP22) Rabbit Monoclonal Primary Antibody	414R-28-ASR	FDA UDI	Class I	Active
MUM1 (EP190) Rabbit Monoclonal Primary Antibody	358R-14	FDA UDI	Class I	Active
Androgen Receptor (EP120) Rabbit Monoclonal Primary Antibody	200R-25	FDA UDI	Class I	Active
BOB.1 (SP92) Rabbit Monoclonal Antibody	760-4593	FDA UDI	Class I	Active
COX-2 (SP21) Rabbit Monoclonal Antibody	240R-15	FDA UDI	Class I	Active
GCDFP-15 (23A3) + Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal	906H-08	FDA UDI	Class I	Active
Olig2 (EP112) Rabbit Monoclonal Primary Antibody	760-5050	FDA UDI	Class I	Active
Helicobacter pylori Rabbit Polyclonal Antibody	215A-75-ASR	FDA UDI	Class I	Active
Ki-67 (MRQ-64) Rabbit Monoclonal Antibody	275R-36	FDA UDI	Class I	Unknown
S100 beta (EP32) Rabbit Monoclonal Primary Antibody	449R-17	FDA UDI	Class I	Active
SDHB (EP288) Rabbit Monoclonal Primary Antibody	466R-17	FDA UDI	Class I	Active
C4d (SP91) Rabbit Monoclonal Antibody	760-4803	FDA UDI	Class I	Active
hCG Rabbit Polyclonal Antibody	760-2650	FDA UDI	Class I	Active
PGP 9.5 Rabbit Polyclonal Antibody	318A-18	FDA UDI	Class I	Active
TSH Rabbit Polyclonal Antibody	211A-17	FDA UDI	Class I	Active
Glucagon (EP74) Rabbit Monoclonal Primary Antibody	259R-18	FDA UDI	Class I	Active
Uroplakin III (SP73) Rabbit Monoclonal Antibody	345R-18	FDA UDI	Class I	Active
S100A1 (EP184) Rabbit Monoclonal Primary Antibody	408R-15	FDA UDI	Class I	Active
Parathyroid Hormone (PTH) (MRQ-31) Mouse Monoclonal Antibody	310M-27	FDA UDI	Class I	Active
PSA (ER-PR8) Mouse Monoclonal Antibody	324M-14	FDA UDI	Class I	Active
BCA-225 (Cu-18) Mouse Monoclonal Antibody	225M-16	FDA UDI	Class I	Active
CEA Rabbit Polyclonal Antibody	236A-14	FDA UDI	Class I	Active
TLE1 (1F5) Mouse Monoclonal Antibody	401M-16	FDA UDI	Class I	Active
INI-1 (MRQ-27) Mouse Monoclonal Antibody	272M-15	EUDAMEDFDA UDI	Class I	Active
Beta-Catenin (14) Mouse Monoclonal Antibody	224M-18	EUDAMEDFDA UDI	Class I	Active
Neurofilament (EP79) Rabbit Monoclonal Primary Antibody	302R-16	FDA UDI	Class I	Active
Spectrin (RBC2/3D5) Mouse Monoclonal Antibody	333M-15	FDA UDI	Class I	Active
CD38 (SP149) Rabbit Monoclonal Antibody	118R-14	EUDAMEDFDA UDI	Class I	Active
ACTH Rabbit Polyclonal Antibody	760-2708	FDA UDI	Class I	Active
Myeloperoxidase (EP151) Rabbit Monoclonal Primary Antibody	289R-24	FDA UDI	Class I	Active
Renal Cell Carcinoma (PN-15) Mouse Monoclonal Antibody	329M-94	FDA UDI	Class I	Active
Cathepsin K (3F9) Mouse Monoclonal Antibody	402M-17	FDA UDI	Class I	Active
Granzyme B (EP230) Rabbit Monoclonal Primary Antibody	262R-17	FDA UDI	Class I	Active
MLH1 (G168-728) Mouse Monoclonal Antibody	285M-15-ASR	FDA UDI	Class I	Active
Mesothelin (EP140) Rabbit Monoclonal Primary Antibody	439R-14	FDA UDI	Class I	Active
Tyrosine Hydroxylase (LNC1) Mouse Monoclonal Antibody	490M-15	FDA UDI	Class I	Active
FOXA1 (2F83) Mouse Monoclonal Primary Antibody	760-4937	FDA UDI	Class I	Active
HBME-1 (HBME-1) Mouse Monoclonal Antibody	283M-15	EUDAMEDFDA UDI	Class I	Active
CD20 (SP32) Rabbit Monoclonal Antibody	120R-16	FDA UDI	Class I	Active
Myeloperoxidase (SP72) Rabbit Monoclonal Antibody	289R-14	FDA UDI	Class I	Active
Oct-2 (MRQ-2) Mouse Monoclonal Antibody	308M-17	FDA UDI	Class I	Active
HMB-45 (HMB-45) Mouse Monoclonal Antibody	282M-97	FDA UDI	Class I	Active
Neurofilament (EP79) Rabbit Monoclonal Primary Antibody	302R-14	FDA UDI	Class I	Active
GH (EP267) Rabbit Monoclonal Primary Antibody	208R-18	FDA UDI	Class I	Active
CD34 (QBEnd/10) Mouse Monoclonal Antibody	134M-16	FDA UDI	Class I	Active
EZH2 (11) Mouse Monoclonal Antibody	415M-16	FDA UDI	Class I	Active
MART-1 (Melan A) (M2-7C10) Mouse Monoclonal Antibody	281M-97	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.