FDA UDI
In Commercial Distribution
🇺🇸 United States
VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody
DI: 07613336100592
·
Model: 790-5094
·
Ventana Medical Systems, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody
- Primary DI
- 07613336100592
- Version / Model
- 790-5094
- Catalog Number
- 07862261001
- Company Name
- Ventana Medical Systems, Inc.
- Labeler DUNS
- 184042521
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-08
- Public Version
- 5
- Public Version Date
- 2022-05-11
- Public Version Status
- Update
- Public Device Record Key
- afa222e8-08eb-405d-968b-14645549e953
Device Description
For use the MMR IHC Panel
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 |
|---|---|---|---|---|
| QNH | Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay | Hematology | 864.1860 | 3 |
| PZJ | Lynch Syndrome Test System | Immunology | 864.1866 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59542 | Hereditary nonpolyposis colon cancer (HNPCC) 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 to evaluate a clinical specimen to diagnose, monitor or predict hereditary nonpolyposis colon cancer (HNPCC) associated with mutations in one of several genes that are important in the detection and repair ofdeoxyribonucleic acid (DNA) base-pair mismatches, which may include MLH1, MSH2, MLH3, MSH6, PMS1 and PMS2. | No | Active |
| 62839 | Postmeiotic segregation increased 2 (PMS2) IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of postmeiotic segregation increased 2 (PMS2), a DNA mismatch repair protein, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613336100592 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN170030 | 000 |
| P200019 | 000 |
| P210001 | 000 |
| P210001 | 001 |