Identity
- Trade Name
- Henry Schein FDA UDI
- Generic Name
- Urine analyser IVD, point-of-care FDA UDI
- Device Name
- URISPEC+ UA READER STARTE FDA UDI
- Model / Reference
- 5701308 FDA UDI
- Description
- URISPEC+ UA READER STARTE FDA UDI
Identifiers
- Catalog Number
- 5701308 FDA UDI
- Primary DI / UDI-DI
- H65811271560 FDA UDI
- FDA Product Code
- JIL FDA UDI
- GMDN Term
- Urine analyser IVD, point-of-care 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 7.5 Centimeter FDA UDI
Category: Urine analyser IVD, point-of-care
Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Urine analyser IVD, point-of-care.
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- Rapid Response — BTNX Inc · Class I
- Mission U120 Urine Analyzer — ACON Laboratories, Inc. · Class I
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
- Henry Schein, Inc.
Sources (1)
- FDA UDI 0a39ded8-888a-4ae5-889e-9c554d61098c 36 fields · synced Jun 8, 2026