FDA UDI
In Commercial Distribution
🇺🇸 United States
VENTANA Antibody Diluent with Casein
DI: 04015630981328
·
Model: 06440002001
·
Ventana Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VENTANA Antibody Diluent with Casein
- Primary DI
- 04015630981328
- Version / Model
- 06440002001
- Catalog Number
- 06440002001
- Company Name
- Ventana Medical Systems, Inc.
- Labeler DUNS
- 184042521
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-08
- Public Version
- 1
- Public Version Date
- 2021-02-16
- Public Version Status
- New
- Public Device Record Key
- 7875d0d7-d5b7-4db2-aa1f-3928af30d85a
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 |
|---|---|---|---|---|
| JCC | pH buffer | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57769 | Immunohistochemistry antibody diluent IVD | A substance or reactant intended to be used for the dilution of antibody solution for use in an enzyme immunohistochemistry assay performed on biological tissues or clinical specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04015630981328 | GS1 |