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Sign in to claim this brandBoditech Med, Inc.
US
Last updated May 30, 2026
Information
- Country
- US
- Address
- —
- Website
- immunostics.com
- —
- —
- [email protected]
- Phone
- 732-9180770
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 689062203
Catalogue (18)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Boditech TSH Control | AFIAS-TSHCLT | FDA UDI | Class II | Active |
| NuActor Viral RNA Extraction kit | UFPK-1 | FDA UDI | N/A | Active |
| Swab-N-Go Home Test COVID-19 Ag | CFPT-17 | FDA UDI | N/A | Active |
| AFIAS-6/VB Analyzer | FPRR020-5 | FDA UDI | Class II | Active |
| Alfis-3 | FPRR028 | FDA UDI | N/A | Active |
| Boditech TSH Calibrator | AFIAS-TSHCAL | FDA UDI | Class I | Active |
| Afias Tsh-Sp | AFIAS TSH-SP | FDA UDI | Class I | Active |
| Afias-50 | FPRR022 | FDA UDI | N/A | Active |
| AFIAS iFOB with AFIAS-50 | CFPO-15-1 | FDA UDI | Class II | Active |
| ichroma Reader | FPRR001 | FDA UDI | Class II | Active |
| ichroma™ iFOB | CFPC-15 | FDA UDI | Class II | Active |
| ichroma™ CRP | i-CHOMRA CRP-25 | FDA UDI | Class II | Active |
| NuActor | FPRR032 | FDA UDI | Class I | Active |
| AFIAS-6/SP Analyzer | FPRR020-4 | FDA UDI | Class I | Active |
| Afias Tsh-Vb | AFIAS TSH-VB | FDA UDI | Class II | Active |
| ichroma Reader | FPRR001 | FDA UDI | Class II | Active |
| AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer | K170232 | FDA 510(k) | Class II | Active |
| I-Chroma Ifob With I-Chroma Reader | K132167 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Boditech Med Inc. Chuncheon Gangwon · KR FEI 3009491259