FDA UDI
In Commercial Distribution
🇺🇸 United States
MagBio Genomics, Inc.
DI: 00850045030445
·
Model: MagQuant™ Plus DNA V2
·
Magbio Genomics, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MagBio Genomics, Inc.
- Primary DI
- 00850045030445
- Version / Model
- MagQuant™ Plus DNA V2
- Catalog Number
- MQP-50096
- 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
- 8a6b3b82-5cb9-4c04-a348-f9436ed4f603
Device Description
DNA quantitation and normalization of DNA concentration
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 |
|---|---|---|---|---|
| 62604 | Nucleic acid library construction kit IVD | A collection of reagents and other associated materials intended to be used for the construction of fragmented nucleic acids [deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] for use in genomic sequencing assays. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs) and is intended to be used for whole genome and/or complementary deoxyribonucleic acid (cDNA) library construction. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850045030445 | GS1 |