| Primary Device ID | 00780311000103 |
| NIH Device Record Key | d24e5b43-11bc-4516-8449-01274a31485a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SAS hCG Serum Control Set |
| Version Model Number | 087712 |
| 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 | 00780311000103 [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 | 2018-11-01 |
| 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 | 2018-12-03SAS™ hCG Serum Controls are intended to be used to monitor the performance and accuracy of SAS™ Serum/Urine hCG pregnancy test kits. These controls are for professional use only. |
| 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 |