FDA UDI
In Commercial Distribution
🇺🇸 United States
IntelliPrep TRIO 240 Sample Preparation System
DI: 04719882810046
·
Model: 80042
·
PlexBio Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IntelliPrep TRIO 240 Sample Preparation System
- Primary DI
- 04719882810046
- Version / Model
- 80042
- Catalog Number
- 80042
- Company Name
- PlexBio Co., Ltd.
- Labeler DUNS
- 656671356
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-28
- Public Version
- 1
- Public Version Date
- 2026-02-05
- Public Version Status
- New
- Public Device Record Key
- 5d6c29d6-a513-48cd-9039-b5f850133c4a
Device Description
The IntelliPrep TRIO 240 Sample Preparation System is designed for the combination use with dedicated IntelliPrep extraction kits to perform automated nucleic acids purification for assay setup. The extracted nucleic acids are intended for downstream molecular biology applications, not directly for the diagnosis, prevention, or treatment of a disease. The IntelliPrep TRIO 240 Sample Preparation System should be used by trained laboratory operators. The downstream diagnostic results obtained by using the extracted nucleic acid with this system should be interpreted in conjunction with clinical or laboratory data accordingly.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJH | Clinical Sample Concentrator | Clinical Chemistry | 862.2310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60736 | Nucleic acid sample preparation instrument IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719882810046 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 133 | Kilogram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- -10°C-55°C/ 10-80% RH non-condensing