FDA UDI
In Commercial Distribution
🇺🇸 United States
Vysis
DI: 00884999025745
·
Model: 06N38-020
·
ABBOTT MOLECULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vysis
- Primary DI
- 00884999025745
- Version / Model
- 06N38-020
- Catalog Number
- 06N38-020
- 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
- 78a76e44-2d19-4add-b7e4-0c54cd2b4a4b
Device Description
Vysis ALK Break Apart FISH 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 |
|---|---|---|---|---|
| OWE | Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60088 | Anaplastic lymphoma kinase (ALK) genetic 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 genetic mutations of the anaplastic lymphoma kinase (ALK) gene, also known as ALK gene. The changes detected at the gene or chromosome level may include ALK gene rearrangement, or NPM-ALK or EML4-ALK fusion genes formed by translocation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884999025745 | GS1 |
Customer Contacts
- Phone
- +1(800)553-7042
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P110012 | 001 |
| P110012 | 002 |
| P110012 | 003 |
| P110012 | 004 |
| P110012 | 005 |
| P110012 | 006 |
| P110012 | 007 |
| P110012 | 008 |
| P110012 | 009 |
| P110012 | 011 |
| P110012 | 012 |
| P110012 | 013 |
| P110012 | 014 |
| P110012 | 015 |
| P110012 | 016 |
| P110012 | 017 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from light
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -10 Degrees Celsius