Is this your brand? Sign in to claim ownership.
Sign in to claim this brandRoche Diagnostics Corp.
US
Last updated May 23, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (1711)
Page 14 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PreciControl Rubella IgG | 4618807160 | FDA UDI | Class I | Active |
| Elecsys HBsAg Confirmatory Test | 09127127190 | FDA UDI | Class II | Active |
| Elecsys FT3 III | 09005811190 | FDA UDI | Class II | Active |
| Elecsys AntiTg Assay | 6368697190 | FDA UDI | Class II | Active |
| gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz | 5168775190 | FDA UDI | Class I | Active |
| Elecsys Cortisol CalSet | 11875124122 | FDA UDI | Class II | Active |
| Elecsys proBNP II STAT Immunoassay | 5390109160 | FDA UDI | Class II | Active |
| Elecsys hGH | 07027486190 | FDA UDI | Class I | Active |
| Total Protein | 11929917216 | FDA UDI | Class II | Unknown |
| Elecsys FT3 III CalSet | 6437222190 | FDA UDI | Class II | Active |
| Rheumatoid Factors II | 20764574322 | FDA UDI | Class II | Active |
| PreciControl HIV Gen II | 06924107162 | FDA UDI | U | Active |
| Elecsys Anti-TSHR | 08496609190 | FDA UDI | Class II | Active |
| Cannabinoids II | 3800105190 | FDA UDI | Class II | Unknown |
| Tinaquant IgM Gen2 | 3507190190 | FDA UDI | Class II | Active |
| Tinaquant Apolipoprotein B ver2 | 5950694190 | FDA UDI | Class II | Active |
| cobas U Calibration Strip | 06390579001 | FDA UDI | Class II | Active |
| Elecsys Anti-HBs | 08343594160 | FDA UDI | Class II | Active |
| Cholinesterase | 11877763216 | FDA UDI | Class I | Active |
| Phosphate (Inorganic) ver.2 | 03183793122 | FDA UDI | Class I | Active |
| Elecsys IgE CalSet | 11930427122 | FDA UDI | Class II | Active |
| Cfas Myoglobin | 4580044190 | FDA UDI | Class II | Active |
| CalSet PTH STAT | 08928509190 | FDA UDI | Class I | Active |
| Sodium electrode | 10825468001 | FDA UDI | Class II | Active |
| Anti-HBs CalCheck | 04985354160 | FDA UDI | Class II | Unknown |
| Preciset DAT Plus II | 3304680190 | FDA UDI | Class II | Active |
| CEDIA Gentamicin II | 11815342216 | FDA UDI | Class II | Unknown |
| Elecsys Tacrolimus | 05889057160 | FDA UDI | Class II | Active |
| Bilirubin Total Gen.3 | 10421436190 | FDA UDI | Class II | Active |
| Cfas DAT Qualitiative Plus | 3304698190 | FDA UDI | Class II | Active |
| Chloride electrode | 03246353001 | FDA UDI | Class II | Active |
| Alkaline Phosphatase acc to IFCC Gen2 | 3333752190 | FDA UDI | Class II | Active |
| Tinaquant Apolipoprotein B ver2 | 3032574122 | FDA UDI | Class II | Active |
| Elecsys CMV IgM | 07027133190 | FDA UDI | Class II | Active |
| PreciControl Lp(a) Gen.2 | 05852650190 | FDA UDI | Class I | Active |
| Valproic Acid | 08058814190 | FDA UDI | Class II | Unknown |
| Calcium Gen2 | 5061431190 | FDA UDI | Class II | Active |
| PreciControl Anti-HBc IgM | 11876333160 | FDA UDI | Class II | Active |
| Elecsys Anti-TSHR | 07026951190 | FDA UDI | Class II | Active |
| Elecsys AntiHAV IgM | 11820591160 | FDA UDI | Class II | Active |
| Elecsys AFP Assay | 4491742160 | FDA UDI | Class II | Active |
| Elecsys FSH | 07027346190 | FDA UDI | Class I | Active |
| Salicylate | 20753580322 | FDA UDI | Class II | Active |
| ISE Standard Low | 11183974216 | FDA UDI | Class II | Active |
| CalCheck IGFBP-3 | 07574797190 | FDA UDI | Class I | Active |
| Tina-quant Antistreptolysin O | 08105472190 | FDA UDI | Class I | Active |
| cobas p 701 Post-Analytical Unit | 05349966001 | FDA UDI | Class I | Active |
| CRP T Control N | 20766321322 | FDA UDI | Class II | Active |
| Precicontrol Troponin T | 3530469190 | FDA UDI | Class I | Active |
| Elecsys HBsAg II | 08814856160 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.