Data / Medical devices / Mexico / Laboratorios Scantibodies S.A. De C.V.

Laboratorios Scantibodies S.A. De C.V.: FDA-registered device maker in TECATE Baja California, Mexico, 2 510(k) clearances

Name: Laboratorios Scantibodies S.A. De C.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Laboratorios Scantibodies S.A. De C.V. is registered with the FDA (registration 3002792284) in TECATE Baja California, Mexico. It lists 24 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 20, 2005. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002792284
Address: Calle Los Vinedos #4100 Parque Industrial El Bajio CP 21430, TECATE Baja California, Mexico, --
Owner or operator: Scantibodies Laboratory Inc. (2020808)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: January 24, 2006
Registered through: 2026
Brand names listed: QuickVue RSV, QuickVue+ Strep A, Sofia Strep A FIA, Sofia hCG FIA

Devices it lists

Device	Product code	Class	Role	Source
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	GQG	1	Contract manufacturer	accessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.	GTY	1	Contract manufacturer	accessdata.fda.gov
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	GNX	1	Contract manufacturer	accessdata.fda.gov
Antisera, All Groups, Streptococcus Spp.	GTZ	1	Contract manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Contract manufacturer	accessdata.fda.gov
Campylobacter Spp.	LQP	1	Contract manufacturer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Contract manufacturer	accessdata.fda.gov
Coronavirus Antigen Detection Test System.	QKP	N	Contract manufacturer	accessdata.fda.gov
Covid-19 Multi-Analyte Antigen Device	QMN	N	Contract manufacturer	accessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus Antigens	PSZ	2	Contract manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	LJC	1	Contract manufacturer	accessdata.fda.gov
Fluorometer, For Clinical Use	KHO	1	Contract manufacturer	accessdata.fda.gov
Helicobacter Pylori	LYR	1	Contract manufacturer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Contract manufacturer	accessdata.fda.gov
Radioimmunoassay, Acth	CKG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Reagent, Borrelia Serological Reagent	LSR	2	Contract manufacturer	accessdata.fda.gov
Reagent, Coronavirus Serological	QKO	N	Contract manufacturer	accessdata.fda.gov
Reagent, Occult Blood	KHE	2	Contract manufacturer	accessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic Acid	QJR	N	Contract manufacturer	accessdata.fda.gov
Reagents, Clostridium Difficile Toxin	LLH	1	Contract manufacturer	accessdata.fda.gov
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings	QVF	2	Contract manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Contract manufacturer	accessdata.fda.gov
System, Test, Infectious Mononucleosis	KTN	2	Contract manufacturer	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 20, 2005	K050748	ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011	CKG	Substantially Equivalent	Scantibodies Laboratory, Inc.	accessdata.fda.gov
June 3, 2002	K021032	ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100	CKG	Substantially Equivalent	Scantibodies Laboratory, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 20, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.