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MONOBIND, INC.

United States·US-MF-000021611

Last updated September 17, 2026

Information

Country
United States
Address
100, North Pointe Drive, Lake Forest, United States
Website
www.monobind.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1 949 951 2665
PRRC Contact
Tony Shatola
EUDAMED SRN
US-MF-000021611
FDA FEI Number
2020726
DUNS Number
083155515

Catalogue (424)

Page 2 of 9
DeviceModel / ReferenceRegistriesClassStatus
DHEA AccuLite CLIA Test System - 192 Wells 7475-300
FDA UDI
Class IActive
Rubella IgM AccuBind ELISA Test System - 96 Wells 6425-300
FDA UDI
Class IIActive
Serum Diluent Concentrate 10X (20.1ml) for High-Value x-H Pylori, x-Tg and x-TPO 144MM
FDA UDI
Class IActive
Monobind AccuLite 17OHP-SI CLIA Kit - 192 Wells 9975-300
FDA UDI
Class IActive
CEA AccuBind ELISA Test System - 192 Wells 1825-300
FDA UDI
Class IIActive
IGF-1 AccuLite CLIA Test System - 96 Wells 13375-300
FDA UDI
Class IActive
SARS-CoV-2 IgA AccuBind ELISA Test System - 96 Wells 11825-300
FDA UDI
NActive
AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 192 Wells 8525-300
FDA UDI
Class IIActive
T3 AccuLite CLIA Test System - 96 Wells 175-300
FDA UDI
Class IIActive
N-17-OHP AccuBind ELISA Test System - 1920 Wells 5525-300
FDA UDI
Class IActive
T3 SBS AccuLite CLIA Test System - 96 Wells 8175-300
FDA UDI
Class IIActive
PTH Whole & Intact AccuLite VAST CLIA Test System - 192 Wells 10075-300
FDA UDI
Class IIActive
Monobind AccuLite Free B-hCG XR CLIA Kit - 96 Wells 10275-300
FDA UDI
Class IIActive
N-17-OHP AccuBind ELISA Test System - 96 Wells 5525-300
FDA UDI
Class IActive
Monobind AccuLite AFP, hCG & uE3 VAST CLIA Kit - 192 Wells 8575-300
FDA UDI
Class IIActive
T3, T4, TSH Thyroid Panel AccuBind VASTAccuBind ELISA Test System - 480 Wells 8025-300
FDA UDI
Class IIActive
AMH AccuLite CLIA Test System - 192 Wells 9775-300
FDA UDI
Class IIActive
TSH AccuLite CLIA Test System - 960 Wells 375-300
FDA UDI
Class IIActive
CMV IgG AccuBind ELISA Test System - 96 Wells 6525-300
FDA UDI
Class IIActive
0 Calibrator Matrix For Multi-Ligands 440MM
FDA UDI
Class IActive
Monobind AccuBind PRL ELISA Kit - 96 Wells 725-300
FDA UDI
Class IActive
IgE AccuBind ELISA Test System - 480 Wells 2525-300
FDA UDI
Class IIActive
Anti-Tg AccuLite CLIA Test System - 96 Wells 1075-300
FDA UDI
Class IIActive
uE3 AccuLite CLIA Test System - 192 Wells 5075-300
FDA UDI
Class IActive
PTH Intact AccuBind ELISA Test System - 96 Wells 9025-300
FDA UDI
Class IIActive
Monobind Qsure H. Pylori Control Set HPC-300
FDA UDI
Class IActive
Anti-H. Pylori IgA AccuBind ELISA Test System - 96 Wells 1625-300
FDA UDI
Class IActive
CMV IgM AccuBind ELISA Test System - 96 Wells 6625-300
FDA UDI
Class IIActive
Myoglobin AccuBind ELISA Test System - 96 Wells 3225-300
FDA UDI
Class IIActive
Monobind AccuBind Free T4 ELISA Kit - 480 Wells 1225-300
FDA UDI
Class IIActive
Vit D Direct AccuLite CLIA Test System - 96 wells 9475-300
FDA UDI
Class IIActive
Free T3 AccuBind ELISA Test System - 480 Wells 1325-300
FDA UDI
Class IIActive
Rubella IgM AccuBind ELISA Test System - 192 Wells 6425-300
FDA UDI
Class IIActive
Tg AccuBind ELISA Test System - 192 Wells 2225-300
FDA UDI
Class IIActive
Monobind AccuBind Vitamin D ELISA Kit - 96 Wells 7725-300
FDA UDI
Class IIActive
17OHP-SI AccuLite CLIA Test System - 96 Wells 9975-300
FDA UDI
Class IActive
Vit D Direct AccuBind ELISA Test System - 192 wells 9425-300
FDA UDI
Class IIActive
Total PSA AccuBind ELISA Test System - 96 Wells 2125-300
FDA UDI
Class IIActive
Free T3 AccuLite CLIA Test System - 96 Wells 1375-300
FDA UDI
Class IIActive
T3, T4, TSH Thyroid Panel AccuBind VAST ELISA Test System - 192 Wells 8025-300
FDA UDI
Class IIActive
PTH Intact AccuBind ELISA Test System - 192 Wells 9025-300
FDA UDI
Class IIActive
N-TSH AccuBind ELISA Test System - 960 Wells 3425-300
FDA UDI
Class IIActive
DHEA AccuBind ELISA Test System - 192 Wells 7425-300
FDA UDI
Class IActive
Monobind Qsure Tumor Marker Control Set TMC-300
FDA UDI
Class IActive
CEA AccuBind ELISA Test System - 96 Wells 1825-300
FDA UDI
Class IIActive
IgE AccuLite CLIA Test System - 960 Wells 2575-300
FDA UDI
Class IIActive
Monobind AccuLite FSH, hCG, LH & PRLs VAST CLIA Kit - 960 Wells 8375-300
FDA UDI
Class IActive
Vit D Direct AccuBind ELISA Test System - 480 wells 9425-300
FDA UDI
Class IIActive
Toxo IgG AccuBind ELISA Test System - 96 Wells 6125-300
FDA UDI
Class IIActive
Aldosterone AccuBind ELISA Test System - 96 Wells 10125-300
FDA UDI
Class IIActive

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