Primary Device ID | 20810172700004 |
NIH Device Record Key | 1ebbd3cd-e057-44e6-859b-1a79ef92799e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box |
Version Model Number | CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen S |
Company DUNS | 117617770 |
Company Name | WatMIND USA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |