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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 4 of 9
DeviceModel / ReferenceRegistriesClassStatus
TSH AccuBind ELISA Test System - 192 Wells 325-300
FDA UDI
Class IIActive
Titin ELISA & CLIA Analyzer IN015-EC
FDA UDI
Class IActive
Rubella IgG AccuBind ELISA Test System - 192 Wells 6325-300
FDA UDI
Class IIActive
AFP AccuBind ELISA Test System - 96 Wells 1925-300
FDA UDI
Class IIActive
PRLs AccuBind ELISA Test System - 96 Wells 4425-300
FDA UDI
Class IActive
TSH AccuBind ELISA Test System - 96 Wells 325-300
FDA UDI
Class IIActive
Vit D Direct AccuBind ELISA Test System - 960 wells 9425-300
FDA UDI
Class IIActive
Free T4 AccuLite CLIA Test System - 96 Wells 1275-300
FDA UDI
Class IIActive
Free T3 AccuLite CLIA Test System - 960 Wells 1375-300
FDA UDI
Class IIActive
PRLs AccuBind ELISA Test System - 192 Wells 4425-300
FDA UDI
Class IActive
DHEA AccuBind ELISA Test System - 96 Wells 7425-300
FDA UDI
Class IActive
Monobind AccuBind hCG Rapid ELISA Kit - 192 Wells 3325-300
FDA UDI
Class IIActive
Ferritin AccuBind ELISA Test System - 192 Wells 2825-300
FDA UDI
Class IIActive
Monobind AccuLite Anti-TPO CLIA Kit - 96 Wells 1175-300
FDA UDI
Class IIActive
Anti-H. Pylori IgG AccuBind ELISA Test System - 96 Wells 1525-300
FDA UDI
Class IActive
C-Peptide AccuLite CLIA Test System - 96 Wells 2775-300
FDA UDI
Class IActive
Free Testosterone AccuBind ELISA Test System - 192 Wells 5325-300
FDA UDI
Class IActive
Titin-s ELISA & CLIA Analyzer IN016-EC
FDA UDI
Class IActive
Free T3, Free T4, TSH Thyroid Panel AccuBind VAST ELISA Test System - 960 Wells 7025-300
FDA UDI
Class IIActive
LH AccuBind ELISA Test System - 96 Wells 625-300
FDA UDI
Class IActive
N-17-OHP AccuBind ELISA Test System - 192 Wells 5525-300
FDA UDI
Class IActive
Monobind AccuBind TSH ELISA Kit - 480 Wells 325-300
FDA UDI
Class IIActive
N-T4 AccuBind ELISA Test System - 960 Wells 2625-300
FDA UDI
Class IIActive
Free Testosterone AccuLite CLIA Test System - 192 Wells 5375-300
FDA UDI
Class IActive
Toxo IgM AccuBind ELISA Test System - 96 Wells 6225-300
FDA UDI
Class IIActive
Monobind AccuLite Free T3 CLIA Kit - 192 Wells 1375-300
FDA UDI
Class IIActive
Anti-TPO AccuBind ELISA Test System - 96 Wells 1125-300
FDA UDI
Class IIActive
Progesterone AccuLite CLIA Test System - 192 Wells 4875-300
FDA UDI
Class IActive
Free T3, Free T4, TSH Thyroid Panel AccuLite VAST CLIA Test System - 960 Wells 7075-300
FDA UDI
Class IIActive
C-Peptide AccuLite CLIA Test System - 192 Wells 2775-300
FDA UDI
Class IActive
ANST AccuBind ELISA Test System - 96 Wells 12425-300
FDA UDI
Class IActive
uE3 AccuBind ELISA Test System - 96 Wells 5025-300
FDA UDI
Class IActive
E2 AccuBind ELISA Test System - 96 Wells 4925-300
FDA UDI
Class IActive
Monobind AccuLite FSH, hCG, LH & PRLs VAST CLIA Kit - 480 Wells 8375-300
FDA UDI
Class IActive
hGH AccuLite CLIA Test System - 96 Wells 1775-300A
FDA UDI
Class IActive
N-TSH AccuBind ELISA Test System - 192 Wells 3425-300
FDA UDI
Class IIActive
T4 AccuBind ELISA Test System - 480 Wells 225-300
FDA UDI
Class IIActive
PAPP-A AccuBind ELISA Test System - 96 Wells 12625-300
FDA UDI
Class IActive
PCT AccuBind ELISA Test System - 96 Wells 9225-300
FDA UDI
Class IIActive
FSH AccuLite CLIA Test System - 192 Wells 475-300
FDA UDI
Class IActive
Titin ELISA Analyzer IN015-E
FDA UDI
Class IActive
CEA AccuLite CLIA Test System - 192 Wells 1875-300
FDA UDI
Class IIActive
PTH Whole & Intact AccuLite VAST CLIA Test System - 96 Wells 10075-300
FDA UDI
Class IIActive
Monobind AccuLite T3, T4, TSH CLIA Kit - 192 Wells 8075-300
FDA UDI
Class IIActive
Insulin AccuBind ELISA Test System - 96 Wells 2425-300
FDA UDI
Class IActive
Monobind AccuLite Folate & Vit B12 VAST CLIA Kit - 192 Wells 7825-300
FDA UDI
Class IIActive
FSH AccuLite CLIA Test System - 96 Wells 475-300
FDA UDI
Class IActive
T4 High Sensitivity AccuBind ELISA Test System - 192 wells 12825-300
FDA UDI
Class IIActive
Vit D Direct AccuLite CLIA Test System - 480 wells 9475-300
FDA UDI
Class IIActive
T4 AccuBind ELISA Test System - 960 Wells 225-300
FDA UDI
Class IIActive

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