Identity
- Trade Name
- Urine Standard (Indirect)(FDA) FDA UDI
- Generic Name
- Multiple electrolyte IVD, calibrator FDA UDI
- Model / Reference
- 105-011385-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904084985 FDA UDI
- 510(k) Number
- K160370 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Multiple electrolyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
MR Unsafe FDA UDI
Category: Multiple electrolyte IVD, calibrator
Urine Standard (Indirect)(FDA) by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple electrolyte IVD, calibrator.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class II
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class II
- Alinity — Abbott · Class II
- Electrolyte Standard Kit — VERICHEM LABORATORIES, INC. · Class II
- Calibrator 2 — TOKYO BOEKI MEDISYS INC. · Class II
- Alfa Wassermann — Alfa Wassermann, Inc.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class II
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class II
Cleared under the same submission
K160370 also covers:
- Accessory Kit of ISE — Shenzhen Mindray Bio-Medical Electronics Co.
- Calibrator rack assembly — Shenzhen Mindray Bio-Medical Electronics Co.
- External water supply module — Shenzhen Mindray Bio-Medical Electronics Co.
- Manual rerun rack assembly — Shenzhen Mindray Bio-Medical Electronics Co.
- Normal sample rack assembly — Shenzhen Mindray Bio-Medical Electronics Co.
- QC rack assembly — Shenzhen Mindray Bio-Medical Electronics Co.
- STAT sample rack assembly — Shenzhen Mindray Bio-Medical Electronics Co.
- Serum Standard (Indirect)(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI 72745802-8ba4-4eab-b48f-885475059710 34 fields · synced Jun 1, 2026