FDA UDI
In Commercial Distribution
🇺🇸 United States
Keratin 5 Polyclonal Chicken Antibody, Purified
DI: 00810034700087
·
Model: 905901
·
BIOLEGEND, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Keratin 5 Polyclonal Chicken Antibody, Purified
- Primary DI
- 00810034700087
- Version / Model
- 905901
- Catalog Number
- 905901
- 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
- 1
- Public Version Date
- 2022-01-10
- Public Version Status
- New
- Public Device Record Key
- 798a6307-dc88-4487-bedc-c76342ddbf78
Device Description
URL: https://www.biolegend.com/en-us/products/keratin-5-polyclonal-chicken-antibody-purified-10957
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 |
|---|---|---|---|---|
| 57767 | Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers 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 | 00810034700087 | GS1 |
Customer Contacts
- Phone
- 858-768-5800
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 100 | Microliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at -20°C. Upon initial thawing, apportion into working aliquots and store at -20°C. Avoid repeated freeze-thaw cycles to prevent denaturing the antibody.
- Type
- Special Storage Condition, Specify
- Special Conditions
- For long-term storage, keep the antibody at -80°C.
- Type
- Storage Environment Temperature
- Temperature Range
- – -20 Degrees Celsius