Identity
- Trade Name
- Cardinal Health FDA UDI
- Generic Name
- Urine sediment IVD, control FDA UDI
- Device Name
- CARDINAL HEALTH® UA CONTROL TUBE SET, 15mL FDA UDI
- Model / Reference
- 89209 FDA UDI
- Description
- CARDINAL HEALTH® UA CONTROL TUBE SET, 15mL FDA UDI
Identifiers
- Catalog Number
- 89209 FDA UDI
- Primary DI / UDI-DI
- 00850015517099 FDA UDI
- FDA Product Code
- JJW FDA UDI
- GMDN Term
- Urine sediment IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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 sediment IVD, control
Cardinal Health by Kova International Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine sediment IVD, control.
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Dipper POCT Level 1&2 Set 62x1.5mL — QUANTIMETRIX CORP. · Class I
- QuanTscopics Control Level 2 Set 4x120mL — QUANTIMETRIX CORP. · Class I
- Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL — QUANTIMETRIX CORP. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Chromascopics Control Level 1&2 Set 4x120mL (International) — QUANTIMETRIX CORP. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- UA-Cellular for UF — Streck · Class II
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
- Kova International Inc
Sources (1)
- FDA UDI cd57a208-65f6-4c11-8e3c-3040163ff317 36 fields · synced Jun 1, 2026