FDA UDI
In Commercial Distribution
🇺🇸 United States
MagBio Genomics, Inc.
DI: 00850045030261
·
Model: HighPrep Tissue DNA/RNA Co-Isolation Kit
·
Magbio Genomics, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MagBio Genomics, Inc.
- Primary DI
- 00850045030261
- Version / Model
- HighPrep Tissue DNA/RNA Co-Isolation Kit
- Catalog Number
- HPT-DR50
- Company Name
- Magbio Genomics, Inc.
- Labeler DUNS
- 078654815
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-13
- Public Version
- 1
- Public Version Date
- 2022-09-21
- Public Version Status
- New
- Public Device Record Key
- bca2b507-d6a6-4b88-b0c5-97192b727fc2
Device Description
Genomic DNA isolation from 30 mg lysate of tissues or cultured cells
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
- No
- Has Serial Number
- Yes
- 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
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 | 00850045030261 | GS1 |
Customer Contacts
- Phone
- (301) 302-0144
- [email protected]