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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 28 of 44

Device	Model / Reference	Registries	Class	Status
p63 (EP174) Rabbit Monoclonal Primary Antibody	482R-17	FDA UDI	Class I	Active
CD2 (EP222) Rabbit Monoclonal Primary Antibody	102R-17	FDA UDI	Class I	Active
Pit-1 (ZM385) Mouse Monoclonal Antibody	496M-15	FDA UDI	Class I	Active
Villin (CWWB1) Mouse Monoclonal Antibody	346M-15	FDA UDI	Class I	Active
PSA (EP109) Rabbit Monoclonal Primary Antibody	324R-16	FDA UDI	Class I	Active
p53 (SP5) Rabbit Monoclonal Antibody	453R-16	FDA UDI	Class I	Active
Renal Cell Carcinoma (PN-15) Mouse Monoclonal Antibody	329M-95	FDA UDI	Class I	Active
GCDFP-15 (23A3) + Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal	906H-07	FDA UDI	Class I	Active
Cytokeratin (34betaE12) Mouse Monoclonal Antibody	334M-87	FDA UDI	Class I	Active
CD71 (EP232) Rabbit Monoclonal Primary Antibody	171R-15	FDA UDI	Class I	Active
Tryptase (G3) Mouse Monoclonal Antibody	342M-18	FDA UDI	Class I	Active
Glial Fibrillary Acidic Protein (GFAP) (SP78) Rabbit Monoclonal Antibody	258R-26	FDA UDI	Class I	Active
c-Myc (EP121) Rabbit Monoclonal Primary Antibody	395R-18	FDA UDI	Class I	Active
Epstein-Barr Virus (CS1-4) Mouse Monoclonal Antibody	245M-15-ASR	FDA UDI	Class I	Active
PHOX2B Rabbit Polyclonal Antibody	422A-15	FDA UDI	Class I	Active
CD45RO (UCHL-1) Mouse Monoclonal Antibody	147M-94	FDA UDI	Class I	Active
CEA Rabbit Polyclonal Antibody	236A-17	FDA UDI	Class I	Active
Glucagon Rabbit Polyclonal Antibody	259A-17	FDA UDI	Class I	Active
PMS2 (MRQ-28) Mouse Monoclonal Antibody	288M-17-ASR	FDA UDI	Class I	Active
Granzyme B (EP230) Rabbit Monoclonal Primary Antibody	262R-18	FDA UDI	Class I	Active
Factor XIIIa (EP3372) Rabbit Monoclonal Primary Antibody	251R-18	FDA UDI	Class I	Active
Vimentin (EP21) Rabbit Monoclonal Primary Antibody	347R-28	FDA UDI	Class I	Active
A-1-Antitrypsin Rabbit Polyclonal Antibody	223A-15	FDA UDI	Class I	Active
CD15 (MMA) Mouse Monoclonal Antibody	115M-18	FDA UDI	Class I	Active
CD19 (MRQ-36) Mouse Monoclonal Antibody	119M-18	FDA UDI	Class I	Active
Androgen Receptor (EP120) Rabbit Monoclonal Primary Antibody	200R-28	FDA UDI	Class I	Active
Claudin 1 Rabbit Polyclonal Antibody	359A-16	FDA UDI	Class I	Active
PHOX2B Rabbit Polyclonal Antibody	422A-16	FDA UDI	Class I	Active
LMO2 (SP51) Rabbit Monoclonal Antibody	370R-15	FDA UDI	Class I	Active
CD57 (NK-1) Mouse Monoclonal Antibody	760-2626	FDA UDI	Class I	Unknown
NKX2.2 (EP336) Rabbit Monoclonal Primary Antibody	445R-14	FDA UDI	Class I	Active
Tyrosine Hydroxylase (LNC1) Mouse Monoclonal Antibody	490M-14	FDA UDI	Class I	Active
CD103 (EP206) Rabbit Monoclonal Primary Antibody	437R-14	FDA UDI	Class I	Active
Prolactin Rabbit Polyclonal Antibody	210A-18	FDA UDI	Class I	Active
Vimentin (V9) Mouse Monoclonal Antibody	347M-10	FDA UDI	Class I	Active
p63 (EP174) Rabbit Monoclonal Primary Antibody	482R-18	FDA UDI	Class I	Active
Thrombomodulin (1009) Mouse Monoclonal Antibody	339M-18	FDA UDI	Class I	Active
BCL2 (SP66) Rabbit Monoclonal Antibody	226R-26	FDA UDI	Class I	Active
Lambda (Lamb14) Mouse Monoclonal Antibody	277M-90	FDA UDI	Class I	Active
MSH6 (44) Mouse Monoclonal Antibody	287M-10-ASR	FDA UDI	Class I	Active
CA19-9 (121SLE) Mouse Monoclonal Antibody	399M-18	FDA UDI	Class I	Active
Calcitonin (SP17) Rabbit Monoclonal Primary Antibody	760-4705	FDA UDI	Class I	Active
S100P (16/f5) Mouse Monoclonal Antibody	376M-94	FDA UDI	Class I	Active
FoxP1 (SP133) Rabbit Monoclonal Antibody	350R-15	FDA UDI	Class I	Active
MLH1 (G168-728) Mouse Monoclonal Antibody	285M-17-ASR	FDA UDI	Class I	Active
Islet-1 (EP283) Rabbit Monoclonal Primary Antibody	431R-16	FDA UDI	Class I	Active
Adipophilin Rabbit Polyclonal Antibody	393A-15	FDA UDI	Class I	Active
CA19-9 (121SLE) Mouse Monoclonal Antibody	399M-14	FDA UDI	Class I	Active
BG8, LewisY (F3) Mouse Monoclonal Antibody	228M-16	FDA UDI	Class I	Active
Tyrosinase (T311) Mouse Monoclonal Antibody	344M-95	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.