FDA UDI
In Commercial Distribution
🇺🇸 United States
Oncomine™ Dx Target Test
DI: 10190302015103
·
Model: A32441
·
LIFE TECHNOLOGIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Oncomine™ Dx Target Test
- Primary DI
- 10190302015103
- Version / Model
- A32441
- Company Name
- LIFE TECHNOLOGIES CORPORATION
- Labeler DUNS
- 080131636
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-22
- Public Version
- 2
- Public Version Date
- 2020-09-23
- Public Version Status
- Update
- Public Device Record Key
- dbb11fce-bd4d-4b46-9312-2b20e91e9676
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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
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 |
|---|---|---|---|---|
| 54557 | Multiple tissue-associated protein/tumour marker IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple proteins or tumour markers associated with specific tissues in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190302015103 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160045 | 000 |