FDA UDI
In Commercial Distribution
🇺🇸 United States
Pepsin for antigen retrieval (RTU)
DI: 08435804520706
·
Model: MAD-024081RVS
·
VITRO SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pepsin for antigen retrieval (RTU)
- Primary DI
- 08435804520706
- Version / Model
- MAD-024081RVS
- Company Name
- VITRO SA
- Labeler DUNS
- 466076718
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-08
- Public Version
- 1
- Public Version Date
- 2025-08-18
- Public Version Status
- New
- Public Device Record Key
- 9c6a1935-44e7-43fa-8fec-791a56ffddea
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 |
|---|---|---|---|---|
| PPM | General Purpose Reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57768 | Immunohistochemistry antibody detection IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an immunohistochemistry assay that is used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08435804520706 | GS1 |