Identity
- Trade Name
- DASH® Negative Control Swabs Kit FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI
- Device Name
- DASH® Negative Control swabs are intended for use as external assay quality controls to monitor the performance of the DASH SARS-CoV-2 & Flu A/B Test performed on the DASH Rapid PCR Instrument, and to confirm that the test cartridge and DASH Rapid PCR Instrument are functioning as intended. FDA UDI
- Model / Reference
- SG-0010 FDA UDI
- Description
- DASH® Negative Control swabs are intended for use as external assay quality controls to monitor the performance of the DASH SARS-CoV-2 & Flu A/B Test performed on the DASH Rapid PCR Instrument, and to confirm that the test cartridge and DASH Rapid PCR Instrument are functioning as intended. FDA UDI
Identifiers
- Catalog Number
- SG-0010 FDA UDI
- Primary DI / UDI-DI
- 00850063063012 FDA UDI
- 510(k) Number
- K241652 FDA UDI
- FDA Product Code
- PMN FDA UDI
- GMDN Term
- Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3920 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
Yes
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
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: Multiple-genus respiratory virus nucleic acid IVD, control
DASH® Negative Control Swabs Kit by Nuclein, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Nuclein, LLC
Sources (1)
- FDA UDI 3de17882-a39a-4dc8-a92c-9c1014ad5417 37 fields · synced May 30, 2026