Identity
- Trade Name
- SalivaBio FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection swab IVD FDA UDI
- Device Name
- SalivaBio Children's Swab (SCS) PK/50 FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- SalivaBio Children's Swab (SCS) PK/50 FDA UDI
Identifiers
- Catalog Number
- 5001.06 FDA UDI
- Primary DI / UDI-DI
- 00859410006207 FDA UDI
- GMDN Term
- Oral/upper respiratory tract specimen collection swab IVD FDA UDI
Classification
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oral/upper respiratory tract specimen collection swab IVD
SalivaBio by Salimetrics Llc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SalivaBio — SALIMETRICS LLC.
- SalivaBio — SALIMETRICS LLC.
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Salimetrics Llc.
Sources (1)
- FDA UDI 2b790956-55ec-491b-9dcd-aea60fe48c39 34 fields · synced May 31, 2026