FDA UDI
In Commercial Distribution
🇺🇸 United States
MagBio Genomics, Inc.
DI: 00850045030001
·
Model: MagXtract Collection Tube
·
Magbio Genomics, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MagBio Genomics, Inc.
- Primary DI
- 00850045030001
- Version / Model
- MagXtract Collection Tube
- Catalog Number
- MXCT-100
- 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
- 2
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 99ced519-4a3c-4b29-aa36-2b47cede3a40
Device Description
Collect sample, lyse to extract RNA/DNA
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 |
|---|---|---|---|---|
| 47922 | Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple virus genera associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850045030018 | GS1 | 100 | In Commercial Distribution | ||
| Primary | 00850045030001 | GS1 |
Customer Contacts
- Phone
- (301) 302-0144
- [email protected]