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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 20 of 44

Device	Model / Reference	Registries	Class	Status
CD16 (SP175) Rabbit Monoclonal Antibody	116R-17	FDA UDI	Class I	Active
CD61 (EP65) Rabbit Monoclonal Primary Antibody	161R-16	FDA UDI	Class I	Active
Arginase-1 (EP261) Rabbit Monoclonal Primary Antibody	380R-28	FDA UDI	Class I	Active
PAX-2 (EP235) Rabbit Monoclonal Primary Antibody	311R-18	FDA UDI	Class I	Active
C4d Rabbit Polyclonal Antibody	760-4436	FDA UDI	Class I	Active
LH Rabbit Polyclonal Antibody	760-2802	FDA UDI	Class I	Active
CMV (DDG9/CCH2) Mouse Monoclonal Antibody	213M-16-ASR	FDA UDI	Class I	Active
Herpes Simplex Virus II (3C5.2) Mouse Monoclonal Antibody	362M-16-ASR	FDA UDI	Class I	Active
Islet-1 (EP283) Rabbit Monoclonal Primary Antibody	431R-14	FDA UDI	Class I	Active
Perforin (MRQ-23) Mouse Monoclonal Antibody	316M-16	FDA UDI	Class I	Active
CD7 (EP132) Rabbit Monoclonal Primary Antibody	107R-14	FDA UDI	Class I	Active
Glial Fibrillary Acidic Protein (GFAP) (SP78) Rabbit Monoclonal Antibody	258R-25	FDA UDI	Class I	Active
CD45R (MB1) Mouse Monoclonal Antibody	760-2624	FDA UDI	Class I	Active
CD19 (MRQ-36) Mouse Monoclonal Antibody	119M-15	FDA UDI	Class I	Active
MUC6 (MRQ-20) Mouse Monoclonal Antibody	293M-97	FDA UDI	Class I	Active
CD2 (EP222) Rabbit Monoclonal Primary Antibody	102R-16	FDA UDI	Class I	Active
SOX-2 (EP103) Rabbit Monoclonal Primary Antibody	371R-25	FDA UDI	Class I	Active
Lysozyme Rabbit Polyclonal Antibody	278A-15	FDA UDI	Class I	Active
CD30 (Ber-H2) Mouse Monoclonal Antibody	130M-97	FDA UDI	Class I	Active
CD5 (EP77) Rabbit Monoclonal Primary Antibody	205R-25	FDA UDI	Class I	Active
Lysozyme Rabbit Polyclonal Antibody	278A-16	FDA UDI	Class I	Active
Cytokeratin, LMW (AE1) Mouse Monoclonal Antibody	301M-14	FDA UDI	Class I	Active
Glypican-3 (1G12) Mouse Monoclonal Antibody	261M-94	FDA UDI	Class I	Active
P504s (13H4) Rabbit Monoclonal Antibody	504R-17-ASR	FDA UDI	Class I	Active
Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal Antibodies	280C-15	FDA UDI	Class I	Active
Granzyme B Rabbit Polyclonal Antibody	262A-16	FDA UDI	Class I	Active
Fascin (55k-2) Mouse Monoclonal Antibody	252M-15	FDA UDI	Class I	Active
Synaptophysin (EP158) Rabbit Monoclonal Primary Antibody	336R-16	FDA UDI	Class I	Active
PSA (EP109) Rabbit Monoclonal Primary Antibody	324R-14	FDA UDI	Class I	Active
Microphthalmia Transcription Factor (MiTF) (C5/D5) Mouse Monoclonal Antibody	284M-94	FDA UDI	Class I	Active
Glucagon Rabbit Polyclonal Antibody	259A-16	FDA UDI	Class I	Active
CD79a (SP18) Rabbit Monoclonal Antibody	179R-16	FDA UDI	Class I	Active
CD16 (SP175) Rabbit Monoclonal Antibody	116R-14	FDA UDI	Class I	Active
Estrogen Receptor (SP1) Rabbit Monoclonal Antibody	249R-15-ASR	FDA UDI	Class I	Active
H3 K36M (RM193) Rabbit Monoclonal Antibody	495R-17	FDA UDI	Class I	Active
LMO2 (SP51) Rabbit Monoclonal Antibody	370R-17	FDA UDI	Class I	Active
Granzyme B (EP230) Rabbit Monoclonal Primary Antibody	262R-15	FDA UDI	Class I	Active
p27Kip1 (SX53G8) Mouse Monoclonal Antibody	427M-96	FDA UDI	Class I	Active
Glutamine Synthetase (GS-6) Mouse Monoclonal Antibody	389M-18	FDA UDI	Class I	Active
Cytokeratin 17 (EP98) Rabbit Monoclonal Primary Antibody	317R-17	FDA UDI	Class I	Active
PSAP (PASE/4LJ) Mouse Monoclonal Antibody	326M-17	FDA UDI	Class I	Active
BCL2 (SP66) Rabbit Monoclonal Antibody	226R-25	FDA UDI	Class I	Active
Thyroglobulin (MRQ-41) Mouse Monoclonal Antibody	340M-94	FDA UDI	Class I	Active
Epstein-Barr Virus (CS1-4) Mouse Monoclonal Antibody	245M-18-ASR	FDA UDI	Class I	Active
Prostein (EP381) Rabbit Monoclonal Primary Antibody	450R-14	FDA UDI	Class I	Active
PD-1 (EP239) Rabbit Monoclonal Primary Antibody	315R-16	FDA UDI	Class I	Active
BCA-225 (Cu-18) Mouse Monoclonal Antibody	225M-14	FDA UDI	Class I	Active
PAX-5 (EP156) Rabbit Monoclonal Primary Antibody	312R-26	FDA UDI	Class I	Active
ACTH Rabbit Polyclonal Antibody	206A-74	FDA UDI	Class I	Active
Lambda (EP172) Rabbit Monoclonal Primary Antibody	277R-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.