FDA UDI
In Commercial Distribution
🇺🇸 United States
HER2 3-in-1 Xenograft Control Slides
DI: 04015630971091
·
Model: 05276101001
·
Ventana Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HER2 3-in-1 Xenograft Control Slides
- Primary DI
- 04015630971091
- Version / Model
- 05276101001
- Catalog Number
- 05276101001
- Company Name
- Ventana Medical Systems, Inc.
- Labeler DUNS
- 184042521
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-29
- Public Version
- 2
- Public Version Date
- 2021-06-18
- Public Version Status
- Update
- Public Device Record Key
- 27907a0d-13e9-4660-b61d-c369f0760ee9
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| KIR | CELLS, ANIMAL AND HUMAN, CULTURED | Hematology | 864.2280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41906 | Nucleic acid hybridization detection IVD, control | A material which is used to verify the performance of an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04015630971091 | GS1 |