FDA UDI
In Commercial Distribution
🇺🇸 United States
BOND™
DI: 05055331334107
·
Model: PA0009-U
·
LEICA BIOSYSTEMS NEWCASTLE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BOND™
- Primary DI
- 05055331334107
- Version / Model
- PA0009-U
- Catalog Number
- PA0009-U
- Company Name
- LEICA BIOSYSTEMS NEWCASTLE LTD
- Labeler DUNS
- 397134693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-16
- Public Version
- 1
- Public Version Date
- 2022-12-26
- Public Version Status
- New
- Public Device Record Key
- 046aaffa-ee81-4c79-b973-b3fd1fa3453f
Device Description
Estrogen Receptor Clone 6F11 Ready-To-Use Primary Antibody For BOND monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human estrogen receptor (ER) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| MYA | Immunohistochemistry Antibody Assay, Estrogen Receptor | Hematology | 864.1860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57210 | Estrogen (oestrogen)/progesterone receptor 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 estrogen (oestrogen) and/or progesterone receptors in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055331334107 | GS1 |
Customer Contacts
- Phone
- +1(800)2480123
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183100 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius