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US
Last updated May 24, 2026
Information
- Country
- US
- Address
- —
- Website
- —
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- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 373050462
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mycoplasma genitalium macrolide resistance IVT A2059C Control | 1 | FDA UDI | Class I | Active |
| Mycoplasma genitalium macrolide resistance IVT A2058G Control | 1 | FDA UDI | Class I | Active |
| Mycoplasma genitamium macrolide resistance IVT A 2059G control | 1 | FDA UDI | Class I | Active |
| Mycoplasma genitalium macrolide resistance IVT A2058T Controls | 1 | FDA UDI | Class I | Active |
| Mycoplasma genitalium macrolide resistance probes | 1 | FDA UDI | Class I | Active |
| Mycoplasma genitalium macrolide resistance primers | 1 | FDA UDI | Class I | Active |
| Mycoplasma genitalium Macrolide Resistance IVT A2058C Control | 1 | FDA UDI | Class I | Active |
| Mycoplama genitalium IVT Wild type control | 1 | FDA UDI | Class I | Active |
| Panther Fusion GBS Assay | K181156 | FDA 510(k) | Class I | Active |
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