FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Angiotensin II RIA
DI: EBUHRKA221
·
Model: RK-A22
·
Bühlmann Laboratories AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Angiotensin II RIA
- Primary DI
- EBUHRKA221
- Version / Model
- RK-A22
- Catalog Number
- RK-A22
- Company Name
- Bühlmann Laboratories AG
- Labeler DUNS
- 481261006
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 46385785-b5b3-4175-a282-e7c9e5f16624
- Distribution End Date
- 2017-11-27
Device Description
The BÜHLMANN Angiotensin II is a double antibody radioimmunoassay designed for the quantitative in vitro diagnostic determination of immunoreactive Angiotensin II in extracted EDTA plasma.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| 52945 | Angiotensin converting enzyme (ACE) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of angiotensin converting enzyme (ACE) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EBUHRKA221 | HIBCC |
Customer Contacts
- Phone
- (844) 300-9799
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K954299 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius