Identity
- Trade Name
- Sterile Narrow Polyester Spun Swab FDA UDI
- Generic Name
- Hu antibody (anti-Hu) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares FDA UDI
- Model / Reference
- 60567 FDA UDI
- Description
- single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860004112723 FDA UDI
- FDA Product Code
- KXG FDA UDI
- GMDN Term
- Hu antibody (anti-Hu) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
Category: Hu antibody (anti-Hu) IVD, kit, fluorescent immunoassay
Sterile Narrow Polyester Spun Swab by Steripack Usa (limited) Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Steripack Usa (limited) Llc
Sources (1)
- FDA UDI 449effc0-ba43-4701-8429-9f1ac3a95d06 33 fields · synced May 30, 2026