FDA UDI
In Commercial Distribution
🇺🇸 United States
IntelliPrep Blood Genomic DNA Extraction Kit
DI: 04719882810237
·
Model: 83026
·
PlexBio Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IntelliPrep Blood Genomic DNA Extraction Kit
- Primary DI
- 04719882810237
- Version / Model
- 83026
- Catalog Number
- 83026
- 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
- 9dad8887-7efe-413b-85b9-9388ee16af90
Device Description
The IntelliPrep Blood Genomic DNA Extraction Kit is intended to be used only with the IntelliPrep TRIO 240 Sample Preparation System for automated nucleic acids purification from human whole blood samples. The product is intended to be used by trained and qualified laboratory users for molecular biology applications and is not intended for the diagnosis or treatment of a disease.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 52521 | Nucleic acid extraction/isolation kit IVD | A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719882810237 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 2.03 | Kilogram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius