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MagCTL Collection Tube (100 tubes)
EUDAMEDFDA UDIClass A (EU MDR)
Ref MXCT-100Model Device for isolation of nucleic acids from sample collection/lysis buffer
Identity
- Trade Name
- MagCTL Collection Tube (100 tubes) EUDAMEDMagBio Genomics, Inc. FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- MagCTL Collection Tube (100 tubes) EUDAMEDCollect sample, lyse to extract RNA/DNA FDA UDI
- Model / Reference
- Device for isolation of nucleic acids from sample collection/lysis buffer EUDAMEDMXCT-100 EUDAMEDMagXtract Collection Tube FDA UDI
- Description
- Collect sample, lyse to extract RNA/DNA FDA UDI
Identifiers
- Catalog Number
- MXCT-100 FDA UDI
- Primary DI / UDI-DI
- 00850045030018 EUDAMED00850045030001 FDA UDI
- Basic UDI-DI
- 0850045030MXCT-100B9 EUDAMED
- Direct Marketing DI
- 00850045030018 EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MagCTL Collection Tube (100 tubes) by MagBio Genomics, Inc. — 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 | 0850045030MXCT-100B9 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- MagBio Genomics, Inc.
- EUDAMED SRN
- US-MF-000038221
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 3caf1875-ccd7-4861-b4c2-de90e450aafd 61 fields · synced Jun 20, 2026
- FDA UDI 99ced519-4a3c-4b29-aa36-2b47cede3a40 35 fields · synced May 30, 2026