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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 29 of 44

Device	Model / Reference	Registries	Class	Status
Calponin (CALP) Mouse Monoclonal Antibody	231M-14	FDA UDI	Class I	Active
PD-L1 (28-8) Rabbit Monoclonal Primary Antibody	438R-18-ASR	FDA UDI	Class I	Active
Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody	340M-15	FDA UDI	Class I	Active
TCL1 (MRQ-7) Mouse Monoclonal Antibody	357M-15	FDA UDI	Class I	Active
EGFR (EP22) Rabbit Monoclonal Primary Antibody	414R-25-ASR	FDA UDI	Class I	Active
Cytokeratin 14 (SP53) Rabbit Monoclonal Antibody	314R-14	FDA UDI	Class I	Active
CD45RO (UCHL-1) Mouse Monoclonal Antibody	147M-95	FDA UDI	Class I	Active
Actin, Muscle Specific (HHF35) Mouse Monoclonal Antibody	201M-98	FDA UDI	Class I	Active
BCL6 (EP278) Rabbit Monoclonal Primary Antibody	227R-26	FDA UDI	Class I	Active
CD20 (L26) Mouse Monoclonal Antibody	120M-88	FDA UDI	Class I	Active
CD43 (MT1) Mouse Monoclonal Antibody	143M-14	FDA UDI	Class I	Active
CD20 (SP32) Rabbit Monoclonal Antibody	120R-18	FDA UDI	Class I	Active
Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody	251M-16	FDA UDI	Class I	Active
BOB.1 (SP92) Rabbit Monoclonal Antibody	294R-17	FDA UDI	Class I	Active
BCA-225 (Cu-18) Mouse Monoclonal Antibody	225M-17	FDA UDI	Class I	Active
SV40 (MRQ-4) Mouse Monoclonal Antibody	351M-16-ASR	FDA UDI	Class I	Active
Myeloperoxidase Rabbit Polyclonal Antibody	289A-77	FDA UDI	Class I	Active
Perforin (MRQ-23) Mouse Monoclonal Antibody	316M-17	FDA UDI	Class I	Active
LH Rabbit Polyclonal Antibody	209A-16	FDA UDI	Class I	Active
CD5 (EP77) Rabbit Monoclonal Primary Antibody	205R-26	FDA UDI	Class I	Active
MUC1 (EP85) Rabbit Monoclonal Primary Antibody	290R-15	FDA UDI	Class I	Active
IMP3 (EP286) Rabbit Monoclonal Primary Antibody	433R-15	FDA UDI	Class I	Active
p120 Catenin (MRQ-5) Mouse Monoclonal Antibody	420M-16	FDA UDI	Class I	Active
CITED1 (5H6) Mouse Monoclonal Antibody	424M-14	FDA UDI	Class I	Active
p21/WAF1 (DCS-60.2) Mouse Monoclonal Antibody	421M-14	FDA UDI	Class I	Active
Glucagon Rabbit Polyclonal Antibody	259A-15	FDA UDI	Class I	Active
IgD (EP173) Rabbit Monoclonal Primary Antibody	268R-17	FDA UDI	Class I	Active
Lambda (Lamb14) Mouse Monoclonal Antibody	277M-96	FDA UDI	Class I	Active
CD31 (EP78) Rabbit Monoclonal Primary Antibody	131R-27	FDA UDI	Class I	Active
NUTM1 (C52B1) Rabbit Monoclonal Antibody	494R-14	FDA UDI	Class I	Active
CD30 (Ber-H2) Mouse Monoclonal Antibody	130M-94	FDA UDI	Class I	Active
TCL1 (MRQ-7) Mouse Monoclonal Antibody	357M-16	FDA UDI	Class I	Active
Calcitonin Rabbit Polyclonal Antibody	229A-18	FDA UDI	Class I	Active
TSH Rabbit Polyclonal Antibody	211A-16	FDA UDI	Class I	Active
Tyrosinase (T311) Mouse Monoclonal Antibody	344M-98	FDA UDI	Class I	Active
CD43 (MT1) Mouse Monoclonal Antibody	143M-18	FDA UDI	Class I	Active
CDK4 (DCS-31) Mouse Monoclonal Antibody	478M-97	FDA UDI	Class I	Unknown
Cytokeratin (CAM 5.2) Mouse Monoclonal Antibody	452M-96	FDA UDI	Class I	Active
Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody	468R-14	EUDAMEDFDA UDI	Class I	Active
IgG Rabbit Polyclonal Antibody	269A-16	FDA UDI	Class I	Active
CD20 (L26) Mouse Monoclonal Antibody	120M-84	FDA UDI	Class I	Active
MART-1 (Melan A) (M2-7C10) Mouse Monoclonal Antibody	281M-98	FDA UDI	Class I	Active
ACTH Rabbit Polyclonal Antibody	206A-75	FDA UDI	Class I	Active
p57/Kip2 (Kp10) Mouse Monoclonal Antibody	457M-98	EUDAMEDFDA UDI	Class I	Active
Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody	251M-15	FDA UDI	Class I	Active
FLI-1 (MRQ-1) Mouse Monoclonal Antibody	254M-17	FDA UDI	Class I	Active
p27Kip1 (SX53G8) Mouse Monoclonal Antibody	427M-95	FDA UDI	Class I	Active
LH Rabbit Polyclonal Antibody	209A-15	FDA UDI	Class I	Active
PAX-2 (EP235) Rabbit Monoclonal Primary Antibody	311R-16	FDA UDI	Class I	Active
IgG Rabbit Polyclonal Antibody	269A-14	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.