FDA UDI
In Commercial Distribution
🇺🇸 United States
FREND Blocking Reagent
DI: 08809317540825
·
Model: FRBR 015
·
NanoEnTek, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FREND Blocking Reagent
- Primary DI
- 08809317540825
- Version / Model
- FRBR 015
- Catalog Number
- FRBR 015
- Company Name
- NanoEnTek, Inc.
- Labeler DUNS
- 687910463
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-24
- Public Version
- 3
- Public Version Date
- 2024-07-23
- Public Version Status
- Update
- Public Device Record Key
- aa32fa8c-2302-4ebe-81e9-564929157681
Device Description
FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The Blocking Reagent is provided in a dried solid state.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| PPM | General Purpose Reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57775 | Immunohistochemistry endogenous protein blocking reagent IVD | A substance or reactant intended to be used for the blocking of endogenous protein reactivity in an 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 | 08809317540825 | GS1 |