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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 13 of 44

Device	Model / Reference	Registries	Class	Status
Actin, Muscle Specific (HHF35) Mouse Monoclonal Antibody	201M-97	FDA UDI	Class I	Active
CD21 (EP3093) Rabbit Monoclonal Antibody	760-4438	FDA UDI	Class I	Active
Somatostatin Receptor 2A (EP149) Rabbit Monoclonal Primary Antibody	486R-17	FDA UDI	Class I	Active
Hemoglobin A (SP212) Rabbit Monoclonal Primary Antibody	760-4936	FDA UDI	Class I	Active
Progesterone Receptor (Y85) Rabbit Monoclonal Primary Antibody	323R-17-ASR	FDA UDI	Class I	Active
Neurofilament (2F11) Mouse Monoclonal Antibody	302M-16	FDA UDI	Class I	Active
Caldesmon (E89) Rabbit Monoclonal Antibody	760-4375	FDA UDI	Class I	Active
NUTM1 (C52B1) Rabbit Monoclonal Antibody	494R-16	FDA UDI	Class I	Active
Hemoglobin A (EPR3608) Rabbit Monoclonal Primary Antibody	360R-16	FDA UDI	Class I	Active
Vimentin (V9) Mouse Monoclonal Antibody	347M-14	FDA UDI	Class I	Active
BCL6 (EP278) Rabbit Monoclonal Primary Antibody	227R-24	FDA UDI	Class I	Active
Stathmin (SP49) Rabbit Monoclonal Antibody	394R-17	FDA UDI	Class I	Active
PSA (ER-PR8) Mouse Monoclonal Antibody	324M-15	FDA UDI	Class I	Active
FSH (EP257) Rabbit Monoclonal Primary Antibody	207R-14	FDA UDI	Class I	Active
MSH2 (G219-1129) Mouse Monoclonal Antibody	286M-14-ASR	FDA UDI	Class I	Active
Gastrin Rabbit Polyclonal Antibody	256A-14	FDA UDI	Class I	Active
Nanog (EP225) Rabbit Monoclonal Primary Antibody	443R-16	FDA UDI	Class I	Active
H3.3 G34W (RM263) Rabbit Monoclonal Antibody	493R-15	FDA UDI	Class I	Active
TSH Rabbit Polyclonal Antibody	211A-14	FDA UDI	Class I	Active
Varicella Zoster Virus (SG1-1, SG1-SG4, NCP-1 & IE-62) Mouse Monoclonal Antibody	364M-18-ASR	FDA UDI	Class I	Active
FSH (EP257) Rabbit Monoclonal Primary Antibody	207R-15	FDA UDI	Class I	Active
Gastrin Rabbit Polyclonal Antibody	256A-15	FDA UDI	Class I	Active
KBA.62 (KBA.62) Mouse Monoclonal Antibody	366M-95	FDA UDI	Class I	Active
SDHB (EP288) Rabbit Monoclonal Primary Antibody	466R-18	FDA UDI	Class I	Active
Inhibin, alpha (MRQ-63) Rabbit Monoclonal Antibody	271R-27	FDA UDI	Class I	Active
Cadherin-17 (SP183) Rabbit Monoclonal Antibody	378R-15	FDA UDI	Class I	Active
hCG Rabbit Polyclonal Antibody	234A-14	FDA UDI	Class I	Active
MSH2 (G219-1129) Mouse Monoclonal Antibody	286M-18-ASR	FDA UDI	Class I	Active
Napsin A Rabbit Polyclonal Antibody	352A-77	FDA UDI	Class I	Active
CD45RO (UCHL-1) Mouse Monoclonal Antibody	147M-96	FDA UDI	Class I	Active
NKX2.2 (EP336) Rabbit Monoclonal Primary Antibody	445R-18	FDA UDI	Class I	Active
Factor XIIIa (EP3372) Rabbit Monoclonal Primary Antibody	251R-16	FDA UDI	Class I	Active
Cyclin D1 (EP12) Rabbit Monoclonal Primary Antibody	241R-44	FDA UDI	Class I	Active
H3 K27M (RM192) Rabbit Monoclonal Antibody	492R-16	FDA UDI	Class I	Active
CD33 (PWS44) Mouse Monoclonal Antibody	133M-18	FDA UDI	Class I	Active
Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal Antibodies	280C-17	FDA UDI	Class I	Active
Napsin A (EP205) Rabbit Monoclonal Primary Antibody	352R-14	FDA UDI	Class I	Active
PAX-7 (MRQ-69) Mouse Monoclonal Antibody	481M-96	FDA UDI	Class I	Unknown
SALL4 (6E3) Mouse Monoclonal Antibody	385M-18	FDA UDI	Class I	Active
CD35 (EP197) Rabbit Monoclonal Primary Antibody	135R-17	FDA UDI	Class I	Active
FSH Rabbit Polyclonal Antibody	207A-74	FDA UDI	Class I	Active
C4d (SP91) Rabbit Monoclonal Antibody	404R-10	FDA UDI	Class I	Active
Collagen Type IV (CIV22) Mouse Monoclonal Antibody	239M-15	FDA UDI	Class I	Active
MUM1 (MRQ-43) Rabbit Monoclonal Antibody	358R-75	FDA UDI	Class I	Active
IgA (EP170) Rabbit Monoclonal Primary Antibody	267R-18	FDA UDI	Class I	Active
Human Placental Lactogen (hPL) Rabbit Polyclonal Antibody	760-4443	FDA UDI	Class I	Active
PMS2 (EPR3947) Rabbit Monoclonal Primary Antibody	288R-17-ASR	FDA UDI	Class I	Active
FOXA1 (2F83) Mouse Monoclonal Antibody	405M-16	FDA UDI	Class I	Active
Langerin (12D6) Mouse Monoclonal Antibody	392M-15	FDA UDI	Class I	Active
Smoothelin (R4A) Mouse Monoclonal Antibody	377M-16	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.