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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
LinkedIn
—
Facebook
—
Phone
+1 949 951 2665
PRRC Contact
Tony Shatola
EUDAMED SRN
US-MF-000021611
FDA FEI Number
2020726
DUNS Number
083155515

Catalogue (424)

Page 7 of 9
DeviceModel / ReferenceRegistriesClassStatus
ACTH AccuBind ELISA Test System - 192 Wells 10625-300
FDA UDI
Class IIActive
N-TSH AccuBind ELISA Test System - 96 Wells 3425-300
FDA UDI
Class IIActive
N-TBG AccuBind ELISA Test System - 96 Wells 8925-300
FDA UDI
Class IIActive
DIG AccuLite CLIA Test System - 96 Wells 975-300
FDA UDI
Class IIActive
AMH AccuLite CLIA Test System - 96 Wells 9775-300
FDA UDI
Class IIActive
FSH, hCG, LH & PRLs VAST AccuBind ELISA Test System - 192 Wells 8325-300
FDA UDI
Class IActive
N-17-OHP AccuBind ELISA Test System - 960 Wells 5525-300
FDA UDI
Class IActive
0 Calibrator Matrix for Steroid (All) and Thyroid (T3, T4) 625MM
FDA UDI
Class IActive
T4 AccuLite CLIA Test System - 96 Wells 275-300
FDA UDI
Class IIActive
hCG Extended Range AccuLite CLIA Test System - 96 Wells 8875-300
FDA UDI
Class IIActive
SARS-CoV-2 IgM AccuBind ELISA Test System - 96 Wells 11725-300
FDA UDI
NActive
DHEA-S AccuBind ELISA Test System - 192 Wells 5125-300
FDA UDI
Class IActive
Testosterone AccuBind ELISA Test System - 96 Wells 3725-300
FDA UDI
Class IActive
Monobind AccuBind C-Peptide ELISA Kit - 192 Wells 2725-300
FDA UDI
Class IActive
N-T4 AccuBind ELISA Test System - 1920 Wells 2625-300
FDA UDI
Class IIActive
hCG Extended Range AccuLite CLIA Test System - 192 Wells 8875-300
FDA UDI
Class IIActive
cTnI AccuLite CLIA Test System - 192 Wells 3875-300
FDA UDI
Class IIActive
Vit B12 AccuLite CLIA Test System - 192 Wells 7675-300
FDA UDI
Class IIActive
Rubella IgG AccuBind ELISA Test System - 96 Wells 6325-300
FDA UDI
Class IIActive
N-TSH AccuBind ELISA Test System - 1920 Wells 3425-300
FDA UDI
Class IIActive
cTnI AccuBind ELISA Test System - 192 Wells 3825-300
FDA UDI
Class IIActive
SARS-CoV-2 IgA AccuBind ELISA Test System - 192 Wells 11825-300
FDA UDI
NActive
SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells 12525-300
FDA UDI
NActive
Aldosterone AccuLite CLIA Test System - 192 Wells 10175-300
FDA UDI
Class IIActive
Monobind Qsure Anti-Tg & Anti-TPO Control Set AIT-101
FDA UDI
Class IActive
Monobind AccuLite FSH, hCG, LH & PRLs VAST CLIA Kit - 192 Wells 8375-300
FDA UDI
Class IActive
Total PSA AccuLite CLIA Test System - 192 Wells 2175-300
FDA UDI
Class IIActive
Progesterone AccuBind ELISA Test System - 96 Wells 4825-300
FDA UDI
Class IActive
ACTH AccuBind ELISA Test System - 96 Wells 10625-300
FDA UDI
Class IIActive
Free Testosterone AccuLite CLIA Test System - 96 Wells 5375-300
FDA UDI
Class IActive
DHEA-S AccuLite CLIA Test System - 96 Wells 5175-300
FDA UDI
Class IActive
CMV IgG AccuBind ELISA Test System - 192 Wells 6525-300
FDA UDI
Class IIActive
ANST AccuLite CLIA Test System - 96 Wells 12475-300
FDA UDI
Class IActive
Calcitonin AccuLite CLIA Test System -192 Wells 9375-300
FDA UDI
Class IIActive
17OHP AccuBind ELISA Test System - 192 Wells 5225-300
FDA UDI
Class IActive
Free T3 AccuBind ELISA Test System - 96 Wells 1325-300
FDA UDI
Class IIActive
TSH Rapid AccuBind ELISA Test System - 192 Wells 6025-300
FDA UDI
Class IIActive
FSH, hCG, LH & PRLs VAST AccuBind ELISA Test System - 960 Wells 8325-300
FDA UDI
Class IActive
Free T3, Free T4, TSH Thyroid Panel AccuLite VAST CLIA Test System - 192 Wells 7075-300
FDA UDI
Class IIActive
IgE AccuLite CLIA Test System - 480 Wells 2575-300
FDA UDI
Class IIActive
Monobind AccuLite IgE CLIA Kit - 96 Wells 2575-300
FDA UDI
Class IIActive
CK-MB AccuBind ELISA Test System - 96 Wells 2925-300
FDA UDI
Class IIActive
Monobind AccuLite Free T4 CLIA Kit - 960 Wells 1275-300
FDA UDI
Class IIActive
Folate, Vit B12 Anemia Panel AccuLite VAST CLIA Test System - 96 Wells 7825-300
FDA UDI
Class IIActive
Monobind AccuLite Cortisol CLIA Kit - 192 Wells 3675-300
FDA UDI
Class IIActive
CK-MB AccuLite CLIA Test System - 192 Wells 2975-300
FDA UDI
Class IIActive
sTfR AccuLite CLIA Test System - 96 Wells 8675-300
FDA UDI
Class IIActive
Free T3 AccuBind ELISA Test System - 192 Wells 1325-300
FDA UDI
Class IIActive
SHBG AccuLite CLIA Test System - 96 Wells 9175-300
FDA UDI
Class IActive
N-T4 AccuBind ELISA Test System - 480 Wells 2625-300
FDA UDI
Class IIActive

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