FDA UDI
In Commercial Distribution
🇺🇸 United States
VENTANA MET (SP44) RxDx Assay
DI: 07613336168974
·
Model: 08866856001
·
Ventana Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VENTANA MET (SP44) RxDx Assay
- Primary DI
- 07613336168974
- Version / Model
- 08866856001
- Catalog Number
- 08866856001
- Company Name
- Ventana Medical Systems, Inc.
- Labeler DUNS
- 184042521
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-20
- Public Version
- 1
- Public Version Date
- 2025-06-30
- Public Version Status
- New
- Public Device Record Key
- 73072f75-4604-4c23-a734-6fdb8973916c
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- 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 |
|---|---|---|---|---|
| SER | Immunohistochemistry Assay, Antibody, MET | Hematology | 864.1860 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67192 | Hepatocyte growth factor receptor (HGFR) 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 hepatocyte growth factor receptor (HGFR), also known as MET proto-oncogene, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613336168974 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P240037 | 000 |