FDA UDI
In Commercial Distribution
🇺🇸 United States
ACTIVE RENIN
DI: 03770024321319
·
Model: RENIN
·
CISBIO BIOASSAYS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACTIVE RENIN
- Primary DI
- 03770024321319
- Version / Model
- RENIN
- Catalog Number
- RENIN
- Company Name
- CISBIO BIOASSAYS
- Labeler DUNS
- 261769626
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-07
- Public Version
- 1
- Public Version Date
- 2021-12-15
- Public Version Status
- New
- Public Device Record Key
- 84baa21b-3db3-4d1d-8c19-81b0bb0ae26a
Device Description
Radioimmunometric assay kit for the quantitative determination of active renin in human plasma. Contains enough reagents for 100 tests. For in vitro diagnostic. Quantitative determination of active renin is used in the diagnostic and treatment of certain types of hypertensions.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- Yes
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| CIB | Radioimmunoassay, Angiotensin I And Renin | Clinical Chemistry | 862.1085 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54348 | Renin IVD, kit, radioimmunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of renin (direct, active, or immunoreactive) in a clinical specimen, using a radioimmunoassay method. It is used to aid in the diagnosis of certain forms of hypertension. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03770024321319 | GS1 |
Customer Contacts
- Phone
- +33466796700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062120 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 100 tests |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius