FDA UDI
In Commercial Distribution
🇺🇸 United States
ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling Kit
DI: 06973685471035
·
Model: 64Tests
·
3D Biomedicine Science & Technology Co., Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling Kit
- Primary DI
- 06973685471035
- Version / Model
- 64Tests
- Catalog Number
- 3103010040
- 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
- 2021-11-30
- Public Version
- 1
- Public Version Date
- 2021-12-08
- Public Version Status
- New
- Public Device Record Key
- 96492ef8-9206-4dc3-9094-e9831165c44d
Device Description
The ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs or anterior nasal swab). The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as technicians and physicians who 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
- No
- 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 | 06973685471035 | GS1 |