FDA UDI
In Commercial Distribution
🇺🇸 United States
Urea Nitrogen Reagent Set
DI: 00812137011916
·
Model: R1 x 500mL, R2 x 125mL
·
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Urea Nitrogen Reagent Set
- Primary DI
- 00812137011916
- Version / Model
- R1 x 500mL, R2 x 125mL
- Catalog Number
- 501-404
- Company Name
- CLINICAL DIAGNOSTIC SOLUTIONS, INC.
- Labeler DUNS
- 048144997
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-10-12
- Public Version
- 3
- Public Version Date
- 2018-04-17
- Public Version Status
- Update
- Public Device Record Key
- cd02d486-6d52-4069-838f-b22f3c491a63
Device Description
For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. Determination of urea nitrogen in serum is widely used as a screening test for renal function. When used in conjunction with the determination of creatinine in serum it is helpful in the differential diagnosis of the three types of azotemia; pre-renal, renal and post-renal.
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | Clinical Chemistry | 862.1770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53587 | Urea IVD, kit, enzyme spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen, using an enzyme spectrophotometry method. It is typically used as an indicator of kidney function and/or to differentiate between prerenal and postrenal azotemia. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812137011916 | GS1 | ||||
| Unit of Use | 00812137012272 | GS1 |
Customer Contacts
- Phone
- 8004533328
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius