FDA UDI
In Commercial Distribution
🇺🇸 United States
Vysis
DI: 00884999001848
·
Model: 02J05-010
·
ABBOTT MOLECULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vysis
- Primary DI
- 00884999001848
- Version / Model
- 02J05-010
- Catalog Number
- 02J05-010
- 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
- b0a5fab5-7693-4be6-8605-7a3cd4c99223
Device Description
ProbeChek PATHVISION HER-2/neu Normal Control Slides
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 |
|---|---|---|---|---|
| NTH | System, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays | Immunology | 866.4700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57049 | C-erbB2/Her2/neu oncoprotein IVD, control | A material which is used to verify the performance of an assay intended to be 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 | 00884999001848 | GS1 |
Customer Contacts
- Phone
- +1(800)553-7042
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN040010 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the ProbeChek PATHVYSION HER-2/neu Normal Control Slides in tightly sealed container with desiccant to protect them from humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius