Identity
- Trade Name
- McKesson FDA UDI
- Generic Name
- Urine analyser IVD, laboratory FDA UDI
- Device Name
- PAPER, NON STICKY F/URINE ANAL FDA UDI
- Model / Reference
- 121-PNS FDA UDI
- Description
- PAPER, NON STICKY F/URINE ANAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20612479197194 FDA UDI
- FDA Product Code
- JIL FDA UDI
- GMDN Term
- Urine analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1340 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine analyser IVD, laboratory
McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine analyser IVD, laboratory.
- Uri-Trak 120 Analyzer — STANBIO LABORATORY, L.P. · Class I
- Urisys 1100 Urine Analyzer — Roche Diagnostics Corp. · Class II
- UA Win10 Kit — BECKMAN COULTER IRELAND INC. · Class I
- Moore Medical — Moore Medical Corp. · Class II
- AUTION EYE™ Control Solution H/L — ARKRAY USA, INC. · Class I
- AUTION™ Diluent SED — ARKRAY USA, INC. · Class I
- Moore Medical — Moore Medical Corp. · Class II
- AUTION MAX™ AX-4060 Analyzer — ARKRAY USA, INC. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI e4976c7f-96d6-4a31-a173-5296d8ecf6e7 33 fields · synced May 30, 2026