HighPrep PCR - DX (5 mL)
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- HighPrep PCR - DX (5 mL) EUDAMEDMagBio Genomics, Inc. FDA UDI
- Generic Name
- Nucleic acid library construction kit IVD FDA UDI
- Device Name
- HighPrep PCR - DX (5 mL) EUDAMEDPost-PCR and post-enzymatic reaction clean-up FDA UDI
- Model / Reference
- Device for post-PCR and post-enzymatic reaction clean-up EUDAMEDAC-60005E EUDAMEDHighPrep™ PCR FDA UDI
- Description
- Post-PCR and post-enzymatic reaction clean-up FDA UDI
Identifiers
- Catalog Number
- AC-60005 FDA UDI
- Primary DI / UDI-DI
- 00850045030124 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850045030AC-60005E9J EUDAMED
- Direct Marketing DI
- 00850045030124 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Nucleic acid library construction kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Nucleic acid sample preparation instrument IVD
The HighPrep PCR - DX (5 mL) is a highly accurate and reliable molecular diagnostic device used for post-PCR and post-enzymatic reaction clean-up. This instrument is designed to provide precise and efficient results in various clinical and research settings.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0850045030AC-60005E9J | 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 159f02ff-1073-476f-93d1-437389627d38 61 fields · synced Jul 12, 2026
- FDA UDI cf12226e-f40a-4e2b-adb5-32b94c13ae1c 35 fields · synced May 30, 2026