Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1645225

FEI Number

1000118544

Entity Name

SA SCIENTIFIC, LTD

City/State/Country

SAN ANTONIO, TX, US

Establishment Address

4919 GOLDEN QUAIL, SAN ANTONIO, TX 78240, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

SA Scientific, Ltd (Owner Number: 9004843)

Owner / Operator Contact Address

4919 Golden Quail, San Antonio, TX 78240, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SAS SAS FluAlert A&B Test SAS Legionella Test SAS Influenza B Test SAS SAS SAS SAS SAS ROTA TEST SAS CANDIDA ANTISERA SAS ASO-LATEX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-05
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2011-12-20
MJH	Legionella, Spp., Elisa	Microbiology	Class 2	866.3300	2011-12-20
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2011-12-20
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2007-12-05
GHM	Test, Sickle Cell	Hematology	Class 2	864.7825	2007-12-05
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2007-12-05
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-05
GQB	Antigens, Cf (Including Cf Control), Reovirus 1-3	Microbiology	Class 1	866.3470	2001-04-14
LRF	Candida Spp., Direct Antigen, Id	Microbiology	Class 2	866.3165	1999-02-25
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	1999-02-25

Official Correspondent

Mathiri Mani

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SA Scientific, Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1645225. Last updated year: 2026. Please use registration number 1645225 when referencing this establishment in official correspondence.