FDA UDI
In Commercial Distribution
🇺🇸 United States
BOND
DI: 05055331316554
·
Model: AR9551
·
LEICA BIOSYSTEMS NEWCASTLE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BOND
- Primary DI
- 05055331316554
- Version / Model
- AR9551
- Catalog Number
- AR9551
- Company Name
- LEICA BIOSYSTEMS NEWCASTLE LTD
- Labeler DUNS
- 397134693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- 2ccbea5d-ffac-434d-8cde-0fc40bce7077
Device Description
BOND Enzyme Pretreatment Kit consists of an enzyme concentrate and an enzyme diluent, which require mixing, and is intended for enzymatic digestion of sections of formalin fixed, paraffin-embedded tissue using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME 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 |
|---|---|---|---|---|
| PPM | General Purpose Reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62840 | Immunohistochemistry protease kit IVD | A collection of reagents and other associated materials, which includes a proteolytic enzyme (e.g., proteinase K and/or pepsin) and a diluent, intended to be used for the enzymatic retrieval of antigenic epitopes from tissue in an enzyme immunohistochemistry assay performed on biological tissues or clinical specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055331316554 | GS1 |
Customer Contacts
- Phone
- +1(800)2480123
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius