FDA UDI
In Commercial Distribution
🇺🇸 United States
BOND
DI: 05055331322234
·
Model: DS9665
·
LEICA BIOSYSTEMS NEWCASTLE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BOND
- Primary DI
- 05055331322234
- Version / Model
- DS9665
- Catalog Number
- DS9665
- Company Name
- LEICA BIOSYSTEMS NEWCASTLE LTD
- Labeler DUNS
- 397134693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-28
- Public Version
- 1
- Public Version Date
- 2021-06-07
- Public Version Status
- New
- Public Device Record Key
- 2a504132-90ee-4bdb-b1b8-1957777357fe
Device Description
ChromoPlex 1 Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker and polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system (includes Leica BOND-MAX system and Leica BOND-III system).
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
- 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 |
|---|---|---|---|---|
| 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 | 05055331322234 | GS1 |
Customer Contacts
- Phone
- +1(800)2480123
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius