Identity
- Trade Name
- RADPAD FDA UDI
- Generic Name
- Multiple Babesia species nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Infant Collimation Shield-Non-Sterile 4 pack-Yellow FDA UDI
- Model / Reference
- 5700-Y-NS FDA UDI
- Description
- Infant Collimation Shield-Non-Sterile 4 pack-Yellow FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852814003346 FDA UDI
- FDA Product Code
- KPY FDA UDI
- GMDN Term
- Multiple Babesia species nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.6500 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Multiple Babesia species nucleic acid IVD, kit, nucleic acid technique (NAT)
Radpad by Worldwide Innovations & Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple Babesia species nucleic acid IVD, kit, nucleic acid technique (NAT).
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 |
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Manufacturer
- Manufacturer
- Worldwide Innovations & Technologies, Inc.
Sources (1)
- FDA UDI d7e9d74a-d41d-4532-ad8f-da360a8a75d4 33 fields · synced Jun 9, 2026