FDA UDI
In Commercial Distribution
🇺🇸 United States
BOND
DI: 05055331332820
·
Model: DS9494
·
LEICA BIOSYSTEMS NEWCASTLE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BOND
- Primary DI
- 05055331332820
- Version / Model
- DS9494
- Catalog Number
- DS9494
- Company Name
- LEICA BIOSYSTEMS NEWCASTLE LTD
- Labeler DUNS
- 397134693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-05
- Public Version
- 1
- Public Version Date
- 2023-05-15
- Public Version Status
- New
- Public Device Record Key
- 819e2f01-0c4d-4bd1-b134-0b2fc5b6794f
Device Description
BOND ChromoPlex II Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP) and polymeric alkaline phosphatase (AP) antibody conjugate system for the visualization of tissue-bound mouse IgG, mouse IgM and rabbit primary antibodies. It is intended for target visualization by immunohistochemistry (IHC) or RNA chromogenic in situ hybridization (RNA CISH) in sections of formalin fixed, paraffin-embedded tissue using the automated BOND-MAX or BOND-III systems.
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 |
|---|---|---|---|---|
| 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 | 05055331332820 | GS1 |
Customer Contacts
- Phone
- +1(800)2480123
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius