FDA UDI
In Commercial Distribution
🇺🇸 United States
BOND™
DI: 05055331303486
·
Model: PB0829
·
LEICA BIOSYSTEMS NEWCASTLE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BOND™
- Primary DI
- 05055331303486
- Version / Model
- PB0829
- Catalog Number
- PB0829
- Company Name
- LEICA BIOSYSTEMS NEWCASTLE LTD
- Labeler DUNS
- 397134693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-19
- Public Version
- 1
- Public Version Date
- 2021-03-29
- Public Version Status
- New
- Public Device Record Key
- 07e48681-8651-4e29-8163-17df852cdeaa
Device Description
HPV Probe (Subtypes 16, 18, 31, 33, 51) is intended to be used for the qualitative identification of the Human Papillomavirus (HPV) DNA in formalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). This probe binds to the five high risk HPV subtypes, 16, 18, 31, 33 and 51.
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 |
|---|---|---|---|---|
| MVU | Reagents, Specific, Analyte | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49995 | Human papillomavirus (HPV) nucleic acid IVD, probe | A defined piece of single-stranded nucleic acid used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used for diagnosing, monitoring or predicting one or multiple strains of human papillomavirus (HPV) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055331303486 | GS1 |
Customer Contacts
- Phone
- +1(800)2480123
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius