FDA UDI
In Commercial Distribution
🇺🇸 United States
Oncomine™ Dx Target DNA Control Kit
DI: 10190302006095
·
Model: A32442
·
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 DNA Control Kit
- Primary DI
- 10190302006095
- Version / Model
- A32442
- 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
- 9
- Public Version Date
- 2025-02-24
- Public Version Status
- Update
- Public Device Record Key
- 7eb0fbb9-c75f-4213-8581-90d368523cec
Device Description
ONC DX TARGET DNA CONTROL
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
- 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 |
|---|---|---|---|---|
| 41906 | Nucleic acid hybridization detection IVD, control | A material which is used to verify the performance of an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190302006095 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160045 | 000 |