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Keystone Nasal / Respiratory Specimen Collection Kit – 100 pack
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Keystone Nasal / Respiratory Specimen Collection Kit – 100 pack FDA UDI
- Generic Name
- General tissue specimen container IVD, fixative/saline FDA UDI
- Device Name
- Nasal / Respiratory Specimen Collection Kit – 100 pack FDA UDI
- Model / Reference
- KMSVKIT-KM01-100 FDA UDI
- Description
- Nasal / Respiratory Specimen Collection Kit – 100 pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003793770 FDA UDI
- FDA Product Code
- JSG FDA UDI
- GMDN Term
- General tissue specimen container IVD, fixative/saline FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2300 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose absorbent tip applicator/swab, single-useGeneral tissue specimen container IVD, fixative/saline
Keystone Nasal / Respiratory Specimen Collection Kit – 100 pack by Keystone Manufacturing — Class I — FDA UDI — listed in FDA GUDID
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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
- Keystone Manufacturing
Sources (1)
- FDA UDI 6c1fee72-2bdc-4887-959f-1fa6871678a8 33 fields · synced Jun 8, 2026