FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Automated Nucleic Acids Extraction System ANDiS 360
DI: 06973685478010
·
Model: ANDiS 360
·
3D Biomedicine Science & Technology Co., Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Automated Nucleic Acids Extraction System ANDiS 360
- Primary DI
- 06973685478010
- Version / Model
- ANDiS 360
- Catalog Number
- 3000000000044
- Company Name
- 3D Biomedicine Science & Technology Co., Limited
- Labeler DUNS
- 561011079
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-20
- Public Version
- 3
- Public Version Date
- 2023-09-21
- Public Version Status
- Update
- Public Device Record Key
- 5e8f69de-6a37-4d83-8ab7-6577b26d1115
- Distribution End Date
- 2023-08-31
Device Description
The device is an automated system, used for extraction and purification of nucleic acid from clinical specimens.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 | 06973685478010 | GS1 |