Identity
- Trade Name
- Molecular Testing Labs FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection swab FDA UDI
- Device Name
- Swab with tube collection kit for respiratory testing FDA UDI
- Model / Reference
- Swab Collection Kit FDA UDI
- Description
- Swab with tube collection kit for respiratory testing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850068539017 FDA UDI
- GMDN Term
- Oral/upper respiratory tract specimen collection swab 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
Molecular Testing Labs by Blackfly Investments, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Cultura™ — Merit Medical Systems, Inc. · Class I
- Sterile Specimen Collection Swab — APPLIED MEDICAL RESOURCES CORP. · Class I
- Rhinostics, Inc. — Rhinostics 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Blackfly Investments, LLC
Sources (1)
- FDA UDI 2590d894-cb19-4e9e-9f48-34b5b2813a1d 33 fields · synced May 30, 2026