ExiPrep™ Dx Mycobacteria Genomic DNA Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- ExiPrep™ Dx Mycobacteria Genomic DNA Kit EUDAMEDFDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- ExiPrep™ Dx Mycobacteria Genomic DNA Kit EUDAMED96 test/kit FDA UDI
- Model / Reference
- K-4418 EUDAMEDFDA UDI
- Description
- 96 test/kit FDA UDI
Identifiers
- Catalog Number
- K-4418 FDA UDI
- Primary DI / UDI-DI
- 08809357174233 EUDAMEDFDA UDI
- Basic UDI-DI
- 880953707K4418B4 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- 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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Nucleic acid extraction/isolation kit IVD
ExiPrep™ Dx Mycobacteria Genomic DNA Kit by Bioneer Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bioneer Corporation
Sources (2)
- FDA UDI 3167b3ce-844f-44f3-b225-520d6ebdcb53 34 fields · synced Jun 11, 2026
- EUDAMED 9cb66982-8ed5-4be1-bf25-7581a4206668 61 fields · synced Jun 11, 2026