SAS FLUALERT A & B, SAS INFLUENZA A TEST
SA SCIENTIFIC LTD.
SA SCIENTIFIC, LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1645225 | 1000118544 | SA SCIENTIFIC, LTD | 1 | N | 2026-01-01 | 4919 GOLDEN QUAIL SAN ANTONIO TX US 78240 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 45200 | 1504664832 | K991193 | SAS HCG-CHECK | LCX | 1999-05-04 |
| 45200 | 1489899135 | K990684 | MODIFICATION OF SAS SERUM/URINE HCG | JHI | 1999-05-10 |
| 45200 | 1838870554 | K965250 | SAS SERUM/URINE HCG | JHI | 1997-02-18 |
| 45200 | 2036062929 | K960947 | SAS SICKLE CELL TEST | GHM | 1996-07-01 |
| 45200 | 1057944925 | K944891 | SAS QUANT HCG URINE | JJX | 1994-11-17 |
| 45200 | 1566166056 | K944785 | SAS QUANT HCG SERUM | JJX | 1995-01-17 |
| 45200 | 1514744359 | K080380 | SAS INFLUENZA A & B TEST | PSZ | 2009-07-23 |
| 45200 | 1659305783 | K061496 | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | MJH | 2007-06-28 |
| 45200 | 1878459942 | K041441 | SAS INFLUENZA A TEST | PSZ | 2004-07-22 |
| 45200 | 2073486135 | K041439 | SAS INFLUENZA B TEST | PSZ | 2004-07-22 |
| 45200 | 1283633945 | K023270 | SAS STREPALERT | GTY | 2002-10-17 |
| 45200 | 1495888058 | ||||
| 45200 | 1017827791 | ||||
| 45200 | 1231311135 | ||||
| 45200 | 1524888074 | ||||
| 45200 | 1962193296 |
Product Codes Associated With Registrations#
PMN#
SAS FLUALERT A&B, SAS INFLUENZA A TEST
SA SCIENTIFIC, INC.
SAS INFLUENZA A & B TEST
SA SCIENTIFIC, INC.
SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
SA SCIENTIFIC LTD.
SAS INFLUENZA A TEST
SA SCIENTIFIC, INC.
SAS INFLUENZA B TEST
SA SCIENTIFIC, INC.
SAS RSV TEST
SA SCIENTIFIC, INC.
SAS BLOOD/SERUM/URINE/URINE HCG
SA SCIENTIFIC, INC.
SAS STREPALERT
SA SCIENTIFIC, INC.
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
SA SCIENTIFIC, INC.
SAS STREP A TEST
SA SCIENTIFIC, INC.
SAS ADENO TEST
SA SCIENTIFIC, INC.
SAS ROTA TEST
SA SCIENTIFIC, INC.
MODIFICATION OF SAS SERUM/URINE HCG
SA SCIENTIFIC, INC.
SAS ONE-STEP PREGNANCY
SA SCIENTIFIC, INC.
SAS HCG-CHECK
SA SCIENTIFIC, INC.
SAS HCG SERUM CONTROLS
SA SCIENTIFIC, INC.
SAS HCG URINE CONTROLS
SA SCIENTIFIC, INC.
CHOICE ACCU-TEST PREGNANCY TEST KIT
SA SCIENTIFIC, INC.
SIGNAL PREGNANCY TEST KIT
SA SCIENTIFIC, INC.
SAS ONE-STEP PREGNANCY
SA SCIENTIFIC, INC.
SAS SICKLE CELL TEST
SA SCIENTIFIC, INC.
SAS SALMONELA H Z24 ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA H F,G,T ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA H G,M,Q ANTISERMU
SA SCIENTIFIC, INC.
SAS SALMONELLA H Z35 ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA H Z4 COMPLEX ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA H Z4, Z24 ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA H Z4, Z32 ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA H Z42 ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS
SA SCIENTIFIC, INC.
SAS SALMONELLA O FACTOR 14 ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA O FACTOR 20 ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA O FACTOR 6 ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM
SA SCIENTIFIC, INC.
SAS SALMONELLA O POLY B ANTISERUM
SA SCIENTIFIC, INC.
GUDID#
Sure-Vue hCG Urine Control set - 087413
2018-11-02
Sure-Vue hCG-STAT Serum Control Set - Sure-Vue hCG-STAT Serum Controls are intended to be used to monitor the performance and accuracy of Sure-Vue Serum/Urine hCG-STAT pregnancy test kits.These controls are for professional use only.
2018-11-02
Sure-Vue hCG Serum Control Set - 087712
2018-11-02
Sure-Vue Pregnancy Strip - 087525
2018-11-02
SAS hCG Urine Control Set - SAS™ hCG Urine Controls are intended to be used to monitor the performance and accuracy of SAS™ Urine hCG pregnancy test kits. These controls are for professional use only.
2018-11-01
SAS Ultimate hCG - SAS™ Ultimate hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only.
2018-11-01
SAS Ultimate hCG - SAS™ Ultimate hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only.
2018-11-01
SAS Ultimate hCG Serum Contol Set - SAS™ Ultimate hCG Serum Controls are intended to be used to monitor the performance and accuracy of SAS™ Ultimate hCG pregnancy test kits. These controls are for professional use only.
2018-11-01
SAS Serum/Urine hCG - SAS™ Serum/Urine hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only.
2018-11-01
SAS Serum/Urine hCG - SAS™ Serum/Urine hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only.
2018-11-02
SAS Serum/Urine hCG - SAS™ Serum/Urine hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only.
2018-11-02
SAS Pregnancy Urine - SAS™ Pregnancy Urine is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. This test is for professional use only.
2018-11-02
SAS Pregnancy Ultimate - The SAS™ Pregnancy Ultimate Test is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only.
2018-11-02
SAS Pregnancy Ultimate - The SAS™ Pregnancy Ultimate Test is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only.
2018-11-02
SAS Pregnancy Strip - SAS™ Pregnancy Strip is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. This test is for professional use only.
2018-11-02
SAS Pregnancy Serum/Urine - SAS™ Pregnancy Serum/Urine is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only.
2018-11-01
SAS One-Step Pregnancy - 087500
2018-11-01
SAS One-Step Pregnancy - SAS™ One-Step Pregnancy is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. This test is for professional use only.
2018-11-02
SAS hCG Serum Control Set - SAS™ 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.
2018-11-01
SAS Pregnancy Serum/Urine - SAS™ Pregnancy Serum/Urine is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only.
2018-11-01
SAS CRP-Latex - The SAS™ CRP-Latex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of C-Reactive Protein in human serum.
2018-11-02
SAS ASO-Latex - 081050
2018-11-02
SAS ASO-Latex - SAS™ ASO-Latex is a rapid latex agglutination test for the qualitative and semi-quantitative determination of Antistreptolysim O antibodies in serum.
2018-11-02
SAS Adeno Test - SAS™ Adeno Test is a membrane-based immunogold assay for the detection of adenovirus and adenovirus antigens. The test is a rapid visual test for the qualitative detection of adenovirus serotypes present in eye swabs, nasal and pharyngeal secretions, fecal samples, and cell culture supernatant. This test is for professional use only.
2018-11-01
SAS Legionella Test - The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires’ disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia. This test is for prescription use only.
2018-11-01
Remel Xpect RSV - Remel Xpect RSV test kit is a rapid, visual assay for qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimen in neonatal and pediatric population. The test is for professional use only.
2018-10-31
Remel Xpect Rotavirus - Remel Xpect Rotavirus is a rapid, membrane-based, immunogold assay for qualitative detection of rotavirus antigen in human fecal specimens. This test is for professional use only.
2018-11-01
Sure-Vue RSV Test - Sure-Vue® RSV antigen test kit is a visual and rapid assay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimens in neonatal and pediatric patients.
2018-11-02
Sure-Vue RSV Test - Sure-Vue® RSV antigen test kit is a visual and rapid assay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimens in neonatal and pediatric patients.
2018-11-02
Sure-Vue Rota Test - Sure-Vue® Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection of Rotavirus antigens in feces as an aid in the diagnosis of acute gastroenteritis caused by Rotavirus infection. This test is for professional use only.
2018-11-02
Sure-Vue Rota Test - Sure-Vue® Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection of Rotavirus antigens in feces as an aid in the diagnosis of acute gastroenteritis caused by Rotavirus infection. This test is for professional use only.
2018-10-24
Sure-Vue Adeno Test - Sure-Vue® Adeno Test is a membrane-based immunogold assay for the detection of adenovirus and adenovirus antigens. The test is a rapid visual test for the qualitative detection of adenovirus serotypes present in eye swabs, nasal and pharyngeal secretions, fecal samples, and cell culture supernatant. This test is for professional use only.
2018-11-02
SAS RSVAlert - SAS™ RSVAlertAlert antigen test kit is a visual and rapid assay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimens in neonatal and pediatric patients. The test is for in-vitro diagnostic use only. It is recommended that negative test results be confirmed by cell culture.
2018-11-02
SAS Rota Test - SAS™ Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection of Rotavirus antigens in feces as an aid in the diagnosis of acute gastroenteritis caused by Rotavirus infection. This test is for professional use only.
2018-11-02
SAS Rota Test - SAS™ Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection of Rotavirus antigens in feces as an aid in the diagnosis of acute gastroenteritis caused by Rotavirus infection. This test is for professional use only.
2018-11-02
SAS Legionella Test - 044020-M
2018-11-02
SAS Legionella Test - 044020-B
2018-11-02
SAS Legionella Test - The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires’ disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia. This test is for prescription use only.
2018-11-02
SAS Herpes Check Test - SAS Herpes Check lateral flow test kit is a visual and rapid assay for the qualitative detection of Herpes Simplex Virus Types 1 & 2 antigens in the eye and genital vesicular fluid.
2018-11-02
CliaWaived Rapid Strep A Test - ST-501
2019-01-28