FDA UDI
In Commercial Distribution
🇺🇸 United States
AUTION™ Sticks 10EA Test Strips
DI: 00015482735265
·
Model: 73526
·
ARKRAY USA, INC.
Product Codes
11
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- AUTION™ Sticks 10EA Test Strips
- Primary DI
- 00015482735265
- Version / Model
- 73526
- Company Name
- ARKRAY USA, INC.
- Labeler DUNS
- 008171162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2017-02-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7b676fcc-441b-4923-a0ae-acb206271d9f
Device Description
Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine.
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 |
|---|---|---|---|---|
| CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1785 | 1 |
| JRE | REFRACTOMETER FOR CLINICAL USE | Clinical Chemistry | 862.2800 | 1 |
| JIO | BLOOD, OCCULT, COLORIMETRIC, IN URINE | Hematology | 864.6550 | 2 |
| JMT | DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) | Clinical Chemistry | 862.1510 | 1 |
| JJB | AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1115 | 1 |
| LJX | TEST, URINE LEUKOCYTE | Hematology | 864.7675 | 1 |
| JIL | METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) | Clinical Chemistry | 862.1340 | 2 |
| KQO | AUTOMATED URINALYSIS SYSTEM | Clinical Chemistry | 862.2900 | 1 |
| CEN | DYE-INDICATOR, PH (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1550 | 1 |
| JIR | INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1645 | 1 |
| JIN | NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1435 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57860 | Urine analyser IVD, laboratory, semi-automated | A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry. The device operates with reduced technician involvement and automation of some, but not all, procedural steps. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00015482735265 | GS1 | ||||
| Unit of Use | 50015482735260 | GS1 |
Customer Contacts
- Phone
- +1(855)646-3108
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160062 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius