FDA UDI
In Commercial Distribution
🇺🇸 United States
Vysis
DI: 00884999027015
·
Model: 07J20-012
·
ABBOTT MOLECULAR INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vysis
- Primary DI
- 00884999027015
- Version / Model
- 07J20-012
- Catalog Number
- 07J20-012
- Company Name
- ABBOTT MOLECULAR INC.
- Labeler DUNS
- 878263359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c5a9e007-7d5e-435a-8e25-325cc36ccdda
Device Description
CEP 12 SpectrumOrange
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 |
|---|---|---|---|---|
| OVQ | Chronic lymphocytic leukemia fish probe kit | Immunology | 866.6040 | 2 |
| KIR | CELLS, ANIMAL AND HUMAN, CULTURED | Hematology | 864.2280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61464 | Chronic lymphocytic leukaemia (CLL) 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 chronic lymphocytic leukaemia (CLL) based on changes at the gene or chromosomal level, which may involve genetic markers on chromosomes 11, 12, 13 and 17. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884999027015 | GS1 |
Customer Contacts
- Phone
- +1(800)553-7042
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K962873 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the unopened CEP 12 DNA probe kit as a unit protected from light and humidity. The 20X SSC salts and NP-40 may be stored separately at room temperature.
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – -20 Degrees Celsius