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 23 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Direct Bilirubin | 11986651018 | FDA UDI | Class II | Unknown |
| Elecsys HCG Test System | 08890587190 | FDA UDI | Class II | Active |
| Elecsys Anti-HBs II | 08498610160 | FDA UDI | Class II | Active |
| Elecsys total PSA | 07027966190 | FDA UDI | Class III | Active |
| Elecsys Anti-HCV II | 07026889190 | FDA UDI | Class II | Active |
| Elecsys Testosterone II | 07027915190 | FDA UDI | Class I | Active |
| Elecsys CMV IgM Immunoassay | 4784618160 | FDA UDI | Class II | Active |
| Magnesium | 05401712190 | FDA UDI | Class I | Active |
| cobas® infinity central lab | 07154003001 | FDA UDI | Class I | Active |
| Accu-Chek Inform II Instrument with RF card | 5060303001 | FDA UDI | Class II | Active |
| Tina-quant IgM Gen.2 | 08057923190 | FDA UDI | Class II | Active |
| Elecsys CA 125 II Calset | 11776240322 | FDA UDI | Class II | Active |
| Tinaquant IgM Gen2 | 3507041190 | FDA UDI | Class II | Active |
| PO2 Electrode | 3111695180 | FDA UDI | Class II | Active |
| Cfas Lipids | 12172623160 | FDA UDI | Class II | Active |
| Ceruloplasmin | 5950848190 | FDA UDI | Class II | Active |
| Control Set DAT III | 3312976190 | FDA UDI | Class I | Active |
| Elecsys Calcitonin Immunoassay | 6445853160 | FDA UDI | Class II | Active |
| Vancomycin | 20737941322 | FDA UDI | Class II | Unknown |
| Elecsys Anti-TPO | 07026935190 | FDA UDI | Class II | Active |
| Phenytoin | 20737879322 | FDA UDI | Class II | Active |
| CalSet II PTH | 08243891190 | FDA UDI | Class II | Active |
| Elecsys Myoglobin STAT Immunoassay | 11820788160 | FDA UDI | Class II | Active |
| Triglycerides | 08058687190 | FDA UDI | Class I | Active |
| Elecsys Vitamin B12 II CalSet | 07212780190 | FDA UDI | Class II | Active |
| Iron Gen.2 | 05401658190 | FDA UDI | Class I | Active |
| gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz | 5401461190 | FDA UDI | Class I | Active |
| Prealbumin | 5950902190 | FDA UDI | Class I | Active |
| Elecsys HBsAg II | 08814848162 | FDA UDI | U | Active |
| Elecsys Vitamin D total III | 09038086190 | FDA UDI | Class II | Active |
| CalSet proBNP II | 07360886190 | FDA UDI | Class II | Active |
| Amphetamines II | 4512880190 | FDA UDI | Class II | Unknown |
| Amikacin | 20767166322 | FDA UDI | Class II | Active |
| Elecsys HBsAg II Auto Confirm | 08741034190 | FDA UDI | Class II | Active |
| Tina-quant ß2-Microglobulin | 08047430190 | FDA UDI | Class II | Unknown |
| CoaguChek XS PT strips | 4625315160 | FDA UDI | Class II | Active |
| Elecsys Estradiol III CalSet | 6656048190 | FDA UDI | Class II | Active |
| Homocysteine Enzymatic Assay | 5385377160 | FDA UDI | Class II | Active |
| Amphetamines II | 4512936190 | FDA UDI | Class II | Active |
| Elecsys Anti-HCV II | 06368921160 | FDA UDI | Class II | Active |
| Elecsys AntiTPO CalSet | 6472931190 | FDA UDI | Class II | Active |
| Direct Bilirubin | 4924495190 | FDA UDI | Class II | Active |
| ONLINE TDM Vancomycin Gen.3 | 08058849190 | FDA UDI | Class II | Unknown |
| ISE Sodium Electrode | 4838084001 | FDA UDI | Class II | Active |
| Urisys 1100 Urine Analyzer | 3617556001 | FDA UDI | Class II | Active |
| Tina-quant Alpha 1-Acid Glycoprotein Gen.2 | 5991960190 | FDA UDI | Class I | Active |
| Tobramycin | 20737925322 | FDA UDI | Class II | Active |
| Elecsys Cortisol III | 07682808190 | FDA UDI | Class II | Active |
| Elecsys BRAHMS PCT | 08828644190 | FDA UDI | Class II | Active |
| Cobas Elecsys AntiTPO | 11820907322 | 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.