FDA UDI
In Commercial Distribution
🇺🇸 United States
PathVysion
DI: 00884999001732
·
Model: 02J01-030
·
ABBOTT MOLECULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PathVysion
- Primary DI
- 00884999001732
- Version / Model
- 02J01-030
- Catalog Number
- 02J01-030
- 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
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4fb5db1f-002f-4a9d-a768-42fabe46a008
Device Description
PathVysion HER-2 DNA Probe 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 |
|---|---|---|---|---|
| MVD | SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57050 | C-erbB2/Her2/neu oncoprotein 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 for the qualitative and/or quantitative detection of c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884999001732 | GS1 |
Customer Contacts
- Phone
- +1(800)553-7042
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P980024 | 001 |
| P980024 | 002 |
| P980024 | 003 |
| P980024 | 004 |
| P980024 | 005 |
| P980024 | 006 |
| P980024 | 007 |
| P980024 | 008 |
| P980024 | 009 |
| P980024 | 010 |
| P980024 | 011 |
| P980024 | 012 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – -20 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from light and humidity