FDA UDI
In Commercial Distribution
🇺🇸 United States
OncoMate MSI Dx Analysis System
DI: 00849811031717
·
Model: MD2140
·
PROMEGA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OncoMate MSI Dx Analysis System
- Primary DI
- 00849811031717
- Version / Model
- MD2140
- Catalog Number
- MD2140
- Company Name
- PROMEGA CORPORATION
- Labeler DUNS
- 089855696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-30
- Public Version
- 1
- Public Version Date
- 2021-10-08
- Public Version Status
- New
- Public Device Record Key
- d0254d6d-f24c-4772-9fc5-f0cf60add546
Device Description
Qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| PZJ | Lynch Syndrome Test System | Immunology | 864.1866 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60202 | Microsatellite instability IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for determining microsatellite instability [abnormal repeated sequences of deoxyribonucleic acid (DNA)] within a tumour tissue specimen, using a nucleic acid technique (NAT). This phenomenon which is associated with defective DNA mismatch repair genes is a feature of certain cancer types including hereditary nonpolyposis colon cancer (HNPCC). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849811031717 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200129 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -10 Degrees Celsius