Identity
- Trade Name
- QIAensemble Decapper System FDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- 9001923 FDA UDI
- Primary DI / UDI-DI
- 04053228003519 FDA UDI
- FDA Product Code
- JQW FDA UDI
- GMDN Term
- Nucleic acid sample preparation instrument IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2750 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
QIAensemble Decapper System by Qiagen, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Qiagen, Inc.
Sources (1)
- FDA UDI 81d03eca-042d-4b0d-923f-e6f92e15cbc7 34 fields · synced May 31, 2026