FDA UDI
In Commercial Distribution
🇺🇸 United States
Novocastra™
DI: 05055331302083
·
Model: RE7110-CE
·
LEICA BIOSYSTEMS NEWCASTLE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Novocastra™
- Primary DI
- 05055331302083
- Version / Model
- RE7110-CE
- Catalog Number
- RE7110-K
- Company Name
- LEICA BIOSYSTEMS NEWCASTLE LTD
- Labeler DUNS
- 397134693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-17
- Public Version
- 1
- Public Version Date
- 2021-05-25
- Public Version Status
- New
- Public Device Record Key
- 1f15ab5b-c628-4ea9-aee2-edcb39b98479
Device Description
Novocastra™ Peroxidase Detection Systems (250 tests) RE7110-K and (500 tests) RE7120-K are for the visualization of mouse IgG, mouse IgM and rabbit IgG primary antibodies. Novocastra™ DAB (250 Slides) RE7190-K, Novocastra™ Biotinylated Secondary Antibody RE7103 and Novocastra™ Streptavidin-HRP RE7104 are component reagents of these systems that are intended for use in the procedure described below.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | Hematology | 864.1860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57767 | Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055331302083 | GS1 |
Customer Contacts
- Phone
- +1(800)2480123
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius