FDA UDI
In Commercial Distribution
🇺🇸 United States
Oncomine™ Dx Target Test User Guides and Assay Definition File
DI: 10190302006071
·
Model: A32461
·
LIFE TECHNOLOGIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Oncomine™ Dx Target Test User Guides and Assay Definition File
- Primary DI
- 10190302006071
- Version / Model
- A32461
- Company Name
- LIFE TECHNOLOGIES CORPORATION
- Labeler DUNS
- 080131636
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-27
- Public Version
- 6
- Public Version Date
- 2024-06-04
- Public Version Status
- Update
- Public Device Record Key
- a6afdd77-c6f0-48bc-ae9d-3b97490a06e7
Device Description
ODXTT UG AND ADF 1.8 - US
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| PQP | Next generation sequencing oncology panel, somatic or germline variant detection system | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61777 | Human genomic analysis interpretive software | An interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic (IVD) results obtained through molecular genetic testing (e.g., whole genome, targeted genome, or exome analyses). It provides predictive and/or diagnostic information (e.g., gene-drug associations, congenital and/or acquired aneuploidy status, genotype-phenotype relationships) used by a professional in the assessment of patient adverse health condition risk, disease prevention, and/or health management, or for lifestyle guidance as pertains to a patient genomic profile. This software is not an IVD device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190302006071 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160045 | 000 |