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- Country
- US
- Address
- 19300 Germantown Rd, Germantown, MD, 20874
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003572099
- DUNS Number
- —
Catalogue (71)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| QIAcuityDx® Universal MasterMix Kit | 1 | FDA UDI | Class I | Active |
| QIAamp DSP Circulating DNA Kit | 1 | FDA UDI | Class I | Active |
| QIAGEN Buffer ASL® | 1 | FDA UDI | Class I | Active |
| artus® HSV-1/2 QS-RGQ MDx Kit | 1 | FDA UDI | Class II | Unknown |
| QIAcuityDx® Universal MasterMix Kit | 1 | EUDAMEDFDA UDI | Class I | Active |
| QIAcube | 1 | FDA UDI | Class I | Active |
| aLF Reader | 1 | FDA UDI | Class I | Active |
| QIAsymphony® DSP DNA Mini Kit | 2 | FDA UDI | Class I | Active |
| QIAsymphony® DSP DNA Midi Kit | 2 | FDA UDI | Class I | Active |
| EZ1 Advanced XL | 1 | FDA UDI | Class I | Active |
| HSV-1 Probe ASR | 1 | FDA UDI | Class I | Active |
| Buffer AVL | 1 | FDA UDI | Class I | Active |
| QIAsymphony DSP DNA Mini Kit | 1 | FDA UDI | Class I | Active |
| QIAamp DSP Circulating NA Kit (50) | 2 | FDA UDI | Class I | Active |
| ipsogen JAK2 RGQ PCR Kit | K172287 | FDA 510(k) | Class II | Active |
| ipsogen JAK2 RGQ PCR Kit | DEN160028 | FDA 510(k) | Class II | Active |
| artus HSV-1/2 QS-RGQ MDx Kit | K142738 | FDA 510(k) | Class II | Active |
| PartoSure test | P160052 | FDA PMA | Class III | Active |
| Virapap Human Papillomavirus Dna Detection Kit | P880009 | FDA PMA | Class III | Active |
| QuantiFeron TB Gold and QuantiFeron TB Gold Plus | P010033 | FDA PMA | Class III | Active |
| Artus Cmv Rgq Mdx Kit | P130027 | FDA PMA | Class II | Active |
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