Identity
- Trade Name
- Rapid Capture System EUDAMEDFDA UDI
- Generic Name
- Specimen processing instrument IVD FDA UDI
- Device Name
- Rapid Capture System EUDAMED
- Model / Reference
- 6000-3101 EUDAMED1 FDA UDI
Identifiers
- Catalog Number
- 6000-3101 FDA UDI
- Primary DI / UDI-DI
- 04053228010821 EUDAMEDFDA UDI
- Basic UDI-DI
- 4053228IHPVRCS000000001K8 EUDAMED
- Direct Marketing DI
- 04053228010821 EUDAMED
- FDA Product Code
- JQW FDA UDI
- EMDN Code
- W02050101 NUCLEIC ACID HYBRIDIZATION UNITS EUDAMED
- GMDN Term
- Specimen processing instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2750 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
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
Rapid Capture System by QIAGEN Sciences LLC — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4053228IHPVRCS000000001K8 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- QIAGEN Sciences LLC
- EUDAMED SRN
- US-MF-000014502
- Authorised Representative
- QIAGEN GmbH DE-AR-000004971
Sources (2)
- EUDAMED 42ab7ca6-12c6-4118-9ad9-828f2c5ed84d 61 fields · synced Jul 10, 2026
- FDA UDI 6d7df1b7-b83a-48e3-8e36-e438ef0a5ae3 33 fields · synced May 30, 2026