FDA UDI
In Commercial Distribution
🇺🇸 United States
D2-40 Lymphatic Endothelial Marker Monoclonal Antibody
DI: 00810034700346
·
Model: 916603
·
BIOLEGEND, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- D2-40 Lymphatic Endothelial Marker Monoclonal Antibody
- Primary DI
- 00810034700346
- Version / Model
- 916603
- Catalog Number
- 916603
- Company Name
- BIOLEGEND, INC.
- Labeler DUNS
- 119240658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-31
- Public Version
- 2
- Public Version Date
- 2022-09-30
- Public Version Status
- Update
- Public Device Record Key
- 7bfae9a7-6e3a-4a1a-a81b-f42dec7ac514
Device Description
URL: https://www.biolegend.com/en-us/products/d2-40-lymphatic-endothelial-marker-monoclonal-antibody-10930
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 |
|---|---|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | Hematology | 864.1860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57168 | D2-40 antigen IVD, kit, enzyme immunohistochemistry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of D2-40 mesothelial/endothelial marker, also known as M2A antigen, in a clinical specimen using an enzyme immunohistochemistry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810034700346 | GS1 |
Customer Contacts
- Phone
- 858-768-5800
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 6 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius