FDA UDI
In Commercial Distribution
🇺🇸 United States
Azostix® Reagent Strips
DI: 00630414551142
·
Model: 10324060
·
Siemens Healthcare Diagnostics Inc.
Product Codes
11
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Azostix® Reagent Strips
- Primary DI
- 00630414551142
- Version / Model
- 10324060
- Catalog Number
- A2830C16
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2021-11-19
- Public Version Status
- Update
- Public Device Record Key
- 62a97647-281a-4f37-9fc0-22e1e91e5c41
Device Description
AZOSTIX® is a firm, plastic strip to which is affixed an impregnated reagent area for estimating the amount of urea nitrogen in whole blood to provide information on renal function.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| JMT | DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) | Clinical Chemistry | 862.1510 | 1 |
| JFY | ENZYMATIC METHOD, CREATININE | Clinical Chemistry | 862.1225 | 2 |
| JIL | METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) | Clinical Chemistry | 862.1340 | 2 |
| CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1785 | 1 |
| LJX | TEST, URINE LEUKOCYTE | Hematology | 864.7675 | 1 |
| JIN | NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1435 | 1 |
| JIR | INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1645 | 1 |
| CEN | DYE-INDICATOR, PH (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1550 | 1 |
| JIO | BLOOD, OCCULT, COLORIMETRIC, IN URINE | Hematology | 864.6550 | 2 |
| JRE | REFRACTOMETER FOR CLINICAL USE | Clinical Chemistry | 862.2800 | 1 |
| JJB | AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1115 | 1 |
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 | 00630414551142 | GS1 | ||||
| Unit of Use | 00630414009544 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K992257 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store in direct sunlight.
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius