FDA UDI
In Commercial Distribution
🇺🇸 United States
96A Viral RNA Auto Extraction & Purification Kit
DI: 06973685471011
·
Model: 96 Tests/Kit
·
3D Biomedicine Science & Technology Co., Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 96A Viral RNA Auto Extraction & Purification Kit
- Primary DI
- 06973685471011
- Version / Model
- 96 Tests/Kit
- Catalog Number
- 3103010059
- Company Name
- 3D Biomedicine Science & Technology Co., Limited
- Labeler DUNS
- 561011079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-13
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- b670ec78-9aab-4208-b17e-2fccdfdb45d5
Device Description
The Viral RNA Auto Extraction & Purification Kit utilize magnetic beads-based technology for automated isolation and purification of RNA from biological samples. The product is intended to be used by professional users that are trained in molecular biological techniques.
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 | 06973685471011 | GS1 |