FDA UDI
In Commercial Distribution
🇺🇸 United States
Vysis
DI: 00884999046610
·
Model: 09N24-020
·
ABBOTT MOLECULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vysis
- Primary DI
- 00884999046610
- Version / Model
- 09N24-020
- Catalog Number
- 09N24-020
- Company Name
- ABBOTT MOLECULAR INC.
- Labeler DUNS
- 878263359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- f7619b52-1ca0-4836-9321-b9cf357eb3e5
Device Description
Vysis LSI DEK SpectrumGreen Probe
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MVU | REAGENTS,SPECIFIC,ANALYTE | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61190 | Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression 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 for the qualitative and/or quantitative detection of mRNA expression of the prostate cancer gene 3 (PCA3) and the gene coding for the prostate specific antigen associated with prostate cancer, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884999046610 | GS1 |
Customer Contacts
- Phone
- +1(800)553-7042
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -15 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in Dark