FDA UDI
In Commercial Distribution
🇺🇸 United States
UroVysion
DI: 00884999002180
·
Model: 02J27-095
·
ABBOTT MOLECULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UroVysion
- Primary DI
- 00884999002180
- Version / Model
- 02J27-095
- Catalog Number
- 02J27-095
- Company Name
- ABBOTT MOLECULAR INC.
- Labeler DUNS
- 878263359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-11-20
- Public Version
- 4
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- 5e51d3b0-4700-49b8-b69e-4ee77f1dcfdd
Device Description
UroVysion Bladder Cancer Kit
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| NSD | Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61101 | Bladder tumour-associated mutation IVD, probe | A defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple acquired mutations e.g., of chromosome 3, 7 and 17, associated with bladder cancer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884999002180 | GS1 |
Customer Contacts
- Phone
- +1(800)553-7042
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030052 | 001 |
| P030052 | 002 |
| P030052 | 003 |
| P030052 | 004 |
| P030052 | 005 |
| P030052 | 006 |
| P030052 | 007 |
| P030052 | 008 |
| P030052 | 009 |
| P030052 | 010 |
| P030052 | 011 |
| P030052 | 012 |
| P030052 | 013 |
| P030052 | 014 |
| P030052 | 015 |
| P030052 | 016 |
| P030052 | 017 |
| P030052 | 018 |
| P030052 | 019 |
| P030052 | 020 |
| P030052 | 021 |
| P030052 | 022 |
| P030052 | 023 |
| P030052 | 024 |
| P030052 | 025 |
| P030052 | 026 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from light and humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – -20 Degrees Celsius