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Sign in to claim this brandU.S. DIAGNOSTICS INC.
US
Last updated May 24, 2026
Information
- Country
- US
- Address
- —
- Website
- usdiagnostics.net
- —
- —
- [email protected]
- Phone
- 866-216-5308
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 828116728
Catalogue (38)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| INFINITY™ Starter Kit | IGM-0024 | FDA UDI | Class II | Active |
| Control™ Meter Kit | IGM-0009 | FDA UDI | Class II | Active |
| Easygluco® Plus Test Strips | IGM-0035 | FDA UDI | Class II | Active |
| INFINITY™ Low Control Solution | IGM-0024 | FDA UDI | Class I | Active |
| EasyGluco™G2 Starter Kit | IGM-0008 | FDA UDI | Class I | Active |
| Control™ Starter Kit | IGM-0009 | FDA UDI | Class II | Active |
| EasyGluco™ Normal Control Solution | IGM-0008 | FDA UDI | Class I | Active |
| EasyGluco™ High Control Solution | IGM-0008 | FDA UDI | Class I | Active |
| INFINITY™ Meter Kit | IGM-0024 | FDA UDI | Class II | Active |
| Control™ Test Strips | IGM-0009 | FDA UDI | Class II | Active |
| EasyGluco™G2 Meter Kit | IGM-0008 | FDA UDI | Class I | Active |
| INFINITY™ Normal Control Solution | IGM-0024 | FDA UDI | Class I | Active |
| EasyGluco™G2 Test Strips | IGM-0008 | FDA UDI | Class II | Active |
| INFINITY™ High Control Solution | IGM-0024 | FDA UDI | Class I | Active |
| EasyGluco™ Low Control Solution | IGM-0008 | FDA UDI | Class I | Active |
| INFINITY™ Test Strips | IGM-0024 | FDA UDI | Class II | Active |
| Activated Partial Thromboplastin Time Test | K862669 | FDA 510(k) | Class I | Active |
| U.s. Diagnostics Liquid Ck Isoenzyme Control | K870738 | FDA 510(k) | Class I | Active |
| U.s. Diagnostics Serum Cholesterol Test | K864081 | FDA 510(k) | Class I | Active |
| Liquid Chemistry Control, Level Ii | K870683 | FDA 510(k) | Class I | Active |
| Prothrombin Time Test | K870596 | FDA 510(k) | Class II | Active |
| U.s. Diagnostics Liquid Ld Isoenzyme Control | K870737 | FDA 510(k) | Class I | Active |
| Uric Acid Test | K864119 | FDA 510(k) | Class I | Active |
| Liquid Chemistry Control, Level I | K870684 | FDA 510(k) | Class I | Active |
| Enzymatic Blood Glucose | K862721 | FDA 510(k) | Class II | Active |
| U.s. Diagnostics Alkaline Phosphatase Test | K863980 | FDA 510(k) | Class II | Active |
| Coagulation Control, Level Ii | K870686 | FDA 510(k) | Class II | Active |
| U.s. Diagnostic Inc. Hemoglobin Test (dry Pack) | K862641 | FDA 510(k) | Class II | Active |
| G4, Model Igm-0004 | K051651 | FDA 510(k) | Class II | Active |
| U.s. Diagnostics Enzymatic Triglyceride Test | K864231 | FDA 510(k) | Class I | Active |
| Urea Nitrogen Test | K863889 | FDA 510(k) | Class II | Active |
| Coagulation Control, Level Iii | K870687 | FDA 510(k) | Class II | Active |
| Easygluco Plus Blood Glucose Monitoring System | K110435 | FDA 510(k) | Class II | Active |
| Cyanmethemoglobin Standard | K871283 | FDA 510(k) | Class II | Active |
| G5 Infinity Blodo Glucose Monitoring System With Model Igm, 0024a | K082201 | FDA 510(k) | Class II | Active |
| Coagulation Control, Level I | K870685 | FDA 510(k) | Class II | Active |
| O.o2 M Calcium Chloride Solution | K870688 | FDA 510(k) | Class II | Active |
| Easygluco, Model Igm-0002 G2 | K061431 | FDA 510(k) | Class II | Active |
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