FDA UDI
In Commercial Distribution
🇺🇸 United States
Novocastra™
DI: 05055331302137
·
Model: RE7101-CE
·
LEICA BIOSYSTEMS NEWCASTLE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Novocastra™
- Primary DI
- 05055331302137
- Version / Model
- RE7101-CE
- Catalog Number
- RE7101
- Company Name
- LEICA BIOSYSTEMS NEWCASTLE LTD
- Labeler DUNS
- 397134693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-09
- Public Version
- 1
- Public Version Date
- 2021-04-19
- Public Version Status
- New
- Public Device Record Key
- abbf529b-7ead-4527-8f1c-3c7e09ce29a0
Device Description
The NovocastraTM Peroxidase Block RE7101 is intended for use in the peroxidase based immunohistochemical (IHC) staining procedures described in the Instructions for Use of the NovocastraTM Peroxidase Detection Systems RE7110-K/RE7120-K, NovocastraTM Concentrated Peroxidase Detection System RE7130-K and NovoLinkTM Polymer Detection Systems RE7140-K/RE7150-K.
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 |
|---|---|---|---|---|
| 57773 | Immunohistochemistry endogenous enzyme blocking reagent IVD | A substance or reactant intended to be used for the blocking of endogenous enzyme reactivity 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 | 05055331302137 | GS1 |
Customer Contacts
- Phone
- +1(800)2480123
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius