Primary Device ID | 00780311000363 |
NIH Device Record Key | 92223f3f-c0df-4bd1-8230-8145677d5295 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SAS RSVAlert |
Version Model Number | 041130 |
Company DUNS | 122092117 |
Company Name | SA SCIENTIFIC, LTD. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00780311000363 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-12-03 |
Device Publish Date | 2018-11-02 |
00780311000882 - CliaWaived Rapid Strep A Test | 2019-02-28 |
00780311000011 - SAS Pregnancy Serum/Urine | 2018-12-03 SAS™ Pregnancy Serum/Urine is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) |
00780311000035 - SAS Adenovirus Controls | 2018-12-03 SAS™ Adenovirus Controls are controls for use with SAS™ Adenovirus test kits. These controls are for professional use only. |
00780311000066 - SAS ASO-Latex | 2018-12-03 SAS™ ASO-Latex is a rapid latex agglutination test for the qualitative and semi-quantitative determination of Antistreptolysim |
00780311000073 - SAS ASO-Latex | 2018-12-03 |
00780311000080 - SAS CRP-Latex | 2018-12-03 The SAS™ CRP-Latex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of C-React |
00780311000103 - SAS hCG Serum Control Set | 2018-12-03 SAS™ hCG Serum Controls are intended to be used to monitor the performance and accuracy of SAS™ Serum/Urine hCG pregnancy te |
00780311000134 - SAS Herpes Check Test | 2018-12-03 SAS Herpes Check lateral flow test kit is a visual and rapid assay for the qualitative detection of Herpes Simplex Virus Types 1 |