FDA UDI
In Commercial Distribution
🇺🇸 United States
Novocastra™
DI: 05055331302090
·
Model: RE7107-CE
·
LEICA BIOSYSTEMS NEWCASTLE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Novocastra™
- Primary DI
- 05055331302090
- Version / Model
- RE7107-CE
- Catalog Number
- RE7107
- Company Name
- LEICA BIOSYSTEMS NEWCASTLE LTD
- Labeler DUNS
- 397134693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-30
- Public Version
- 1
- Public Version Date
- 2021-05-10
- Public Version Status
- New
- Public Device Record Key
- 99e5bbeb-caa2-442d-829a-92e3fc87f8bc
Device Description
Novocastra™ Hematoxylin RE7107 is intended for use in immunohistochemical (IHC) staining procedures such as those described in the Instructions for Use of the Novocastra™ Peroxidase Detection Systems RE7110-K/RE7120-K, Novocastra™ Concentrated Peroxidase Detection System RE7130-K and Novolink™ 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 |
|---|---|---|---|---|
| 43587 | Biological stain IVD | A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055331302090 | GS1 |
Customer Contacts
- Phone
- +1(800)2480123
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius