Abbott mSample Preparation System DNA
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Abbott mSample Preparation System EUDAMEDFDA UDIAbbott mSample Preparation System DNA FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- Abbott mSample Preparation System EUDAMEDAbbott mSample Preparation System DNA is a nucleic acid extraction system used for laboratory isolation of DNA from biological samples. FDA UDIAbbott mSample Preparation System is a nucleic acid extraction system used for laboratory isolation of RNA from biological samples. FDA UDI
- Model / Reference
- 04J70-24 EUDAMEDFDA UDI06K12-24 FDA UDI
- Description
- Abbott mSample Preparation System DNA is a nucleic acid extraction system used for laboratory isolation of DNA from biological samples. FDA UDIAbbott mSample Preparation System is a nucleic acid extraction system used for laboratory isolation of RNA from biological samples. FDA UDI
Identifiers
- Catalog Number
- 06K12-24 FDA UDI04J70-24 FDA UDI
- Primary DI / UDI-DI
- 00849811004445 EUDAMEDFDA UDI00849811004452 FDA UDI
- Basic UDI-DI
- 00849811004445JW 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
Yes
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
Abbott mSample Preparation System DNA by Promega Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
- abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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
- Promega Corporation
Sources (3)
- FDA UDI 5ce89c7e-9508-408e-aec4-7084828cb28c 36 fields · synced Jul 11, 2026
- FDA UDI be2cd1b1-a24a-4663-b6b4-e43d732ab969 36 fields · synced May 30, 2026
- EUDAMED 136cd4d8-a7a8-498f-a30b-c78b4a206cec 61 fields · synced Jul 11, 2026