FDA UDI
In Commercial Distribution
🇺🇸 United States
Anti PD-L1 Antibody
DI: B766C310500
·
Model: C31050
·
INCELLDX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Anti PD-L1 Antibody
- Primary DI
- B766C310500
- Version / Model
- C31050
- Catalog Number
- C31050
- Company Name
- INCELLDX, INC.
- Labeler DUNS
- 833074623
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-05
- Public Version
- 1
- Public Version Date
- 2020-02-13
- Public Version Status
- New
- Public Device Record Key
- 3e64ee7a-43d6-4aea-a77b-0c3c8197e1dd
Device Description
Anti PD-L1 Antibody is a rabbit monoclonal antibody to PD-L1 [28-8] conjugated with Alexa Fluor 647.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 62046 | Programmed death-ligand 1 (PD-L1) IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of programmed death-ligand 1 (PD-L1), also known as CD274, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B766C310500 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 55 | Microliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius