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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 8 of 9
DeviceModel / ReferenceRegistriesClassStatus
Anti-H. Pylori IgG AccuLite CLIA Test System - 96 Wells 1575-300
FDA UDI
Class IActive
IGF-1 AccuBind ELISA Test System - 192 Wells 13325-300
FDA UDI
Class IActive
D-Dimer AccuLite CLIA Test System - 96 Wells 12075-300
FDA UDI
Class IIActive
Progesterone AccuLite CLIA Test System - 96 Wells 4875-300
FDA UDI
Class IActive
PRLs AccuLite CLIA Test System - 192 Wells 4475-300
FDA UDI
Class IActive
sTfR AccuBind ELISA Test System - 192 Wells 8625-300
FDA UDI
Class IIActive
N-TSH AccuBind ELISA Test System - 480 Wells 3425-300
FDA UDI
Class IIActive
N-TBG AccuBind ELISA Test System - 192 Wells 8925-300
FDA UDI
Class IIActive
T3 Uptake AccuLite CLIA Test System - 192 Wells 575-300
FDA UDI
Class IIActive
N-17-OHP AccuBind ELISA Test System - 480 Wells 5525-300
FDA UDI
Class IActive
Folate AccuLite CLIA Test System - 96 Wells 7575-300
FDA UDI
Class IIActive
Monobind AccuBind 17OHP-SI ELISA Kit - 96 Wells 9925-300
FDA UDI
Class IActive
TSH AccuLite CLIA Test System - 480 Wells 375-300
FDA UDI
Class IIActive
CA 19-9 AccuBind ELISA Kit - 96 wells 3925-300A
EUDAMEDFDA UDI
Class CActive
AFP, CEA & PSA AccuBind VAST ELISA Kit - 960 wells 8425-300E
EUDAMEDFDA UDI
Class CActive
NeoLumax® CLIA Analyzer IN010
EUDAMEDFDA UDI
Class AActive
PrisMatic® ELISA Analyzer IN013
EUDAMEDFDA UDI
Class AActive
Autoplex® G2 ELISA & CLIA Analyzer IN006-2
EUDAMEDFDA UDI
Class AActive
CA 15-3 AccuLite CLIA Kit - 192 wells 5625-300B
EUDAMEDFDA UDI
Class CActive
Free PSA AccuBind ELISA Kit - 96 wells 2325-300A
EUDAMEDFDA UDI
Class CActive
Lh Radioimmunoassay Test System K820760
FDA 510(k)
Class IActive
Fsh Radioimmunoassay Test System K820048
FDA 510(k)
Class IActive
Triodothyronine (tc) Coated Tube Ria K926345
FDA 510(k)
Class IIActive
T3 Uptake Test K780361
FDA 510(k)
Class IIActive
Anti-Thyroglobulin (tg) Microplate Elisa K971835
FDA 510(k)
Class IIActive
Thyroxine (t4) Coated Tube Ria K921935
FDA 510(k)
Class IIActive
Follicle Stimulating Hormone (fsh) Microplate Elisa (425-300) K972720
FDA 510(k)
Class IActive
Total Triiodothyronine(t3) Microplate Eia K971779
FDA 510(k)
Class IIActive
Digoxin Coated Tube Ria K922353
FDA 510(k)
Class IIActive
Hcg Ria Test System K854958
FDA 510(k)
Class IIActive
Tsh Ria Test System K771222
FDA 510(k)
Class IIActive
Radioimmunoassay Test System Prl K830412
FDA 510(k)
Class IActive
Prolactin (prl) Hormone Microplate Elisa K971921
FDA 510(k)
Class IActive
Free T4 (thytoxine) Microplate Eia Test Models # 1225-300 K020548
FDA 510(k)
Class IIActive
Accubind Neonatal T4 Microplate Eia, Model 2625-300 K030860
FDA 510(k)
Class IIActive
Accubind Neo-Tsh Microwell Elisa, Model 3425-300 K063437
FDA 510(k)
Class IIActive
T4 Ria Test System K771221
FDA 510(k)
Class IIActive
Thyrotropin(tsh) Elisa K971780
FDA 510(k)
Class IIActive
T-Uptake Microplate Eia K980088
FDA 510(k)
Class IIActive
T3 Ria Test System K771220
FDA 510(k)
Class IIActive
Anti-Thyroid Peroxidase (tpo) Microplate Elisa K971834
FDA 510(k)
Class IIActive
Free Testosterone AccuBind ELISA Test System K181017
FDA 510(k)
Class IActive
Total Throxine Microplate Eia(225-300) K971709
FDA 510(k)
Class IIActive
AFP, CEA & PSA AccuLite VAST CLIA Kit - 192 wells 8475-300B
EUDAMEDFDA UDI
Class CActive
CA-125 AccuLite CLIA Kit - 96 wells 3075-300A
EUDAMEDFDA UDI
Class CActive
LuMatic® CLIA Analyzer IN008
EUDAMEDFDA UDI
Class AActive
CEA NEXT GEN AccuLite CLIA Kit - 192 wells 4675-300B
EUDAMEDFDA UDI
Class CActive
PSA-XS AccuBind ELISA Kit - 96 Well 8725-300A
EUDAMEDFDA UDI
Class CActive
CA 19-9 AccuLite CLIA Kit - 192 wells 3975-300B
EUDAMEDFDA UDI
Class CActive
Monobind IN002
EUDAMEDFDA UDI
Class AActive

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