Identity
- Trade Name
- AUTION™ Uriflet 9HA Test Strips FDA UDI
- Generic Name
- Urine analyser IVD, laboratory FDA UDI
- Device Name
- Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine. FDA UDI
- Model / Reference
- 73521 FDA UDI
- Description
- Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987486735212 FDA UDI
- 510(k) Number
- K121456 FDA UDI
- FDA Product Code
- KQO FDA UDI
- GMDN Term
- Urine analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine analyser IVD, laboratory
AUTION™ Uriflet 9HA Test Strips by Arkray Usa, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121456 also covers:
- AUTION™ Diluent BAC — ARKRAY USA, INC.
- AUTION™ Diluent SED — ARKRAY USA, INC.
- AUTION™ Sheath Solution — ARKRAY USA, INC.
- AUTION™ Staining Solution BAC — ARKRAY USA, INC.
- AUTION™ Staining Solution SED — ARKRAY USA, INC.
- Aution™ AU Control Solution — ARKRAY USA, INC.
- Aution™ Hybrid AU-4050 Chemical Analyzer — ARKRAY USA, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Arkray Usa, Inc.
Sources (1)
- FDA UDI 8c54dfe3-52b3-494b-95fa-3280616f62b9 36 fields · synced May 31, 2026