Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2020808

FEI Number

2020808

Entity Name

SCANTIBODIES LABORATORY, INC.

City/State/Country

SANTEE, CA, US

Establishment Address

9336 ABRAHAM WAY, SANTEE, CA 92071, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Scantibodies Laboratory Inc. (Owner Number: 2020808)

Owner / Operator Contact Address

9336 Abraham Way, --, Santee, CA 92071, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-11-18
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2020-11-20
CKG	Radioimmunoassay, Acth	Clinical Chemistry	Class 2	862.1025	2006-01-24
LQP	Campylobacter Spp.	Microbiology	Class 1	866.3110	2022-02-02
CKG	Radioimmunoassay, Acth	Clinical Chemistry	Class 2	862.1025	2014-05-21
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-31
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2021-01-11
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2021-01-11

Official Correspondent

Angela Cancino

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Scantibodies Laboratory Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3026664926	SCANTIBODIES LABORATORY INC.	San Diego, CA, US
3002792284	LABORATORIOS SCANTIBODIES S.A. DE C.V.	TECATE Baja California, MX
3033507883	Laboratorios Scantibodies, S.A. de C.V.	Tijuana Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

Similar Registrations

Registration Number	Establishment Name	Location
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9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3008054239	CORE TECHNOLOGY CO., LTD.	Changping District Beijing, CN
3016761091	Shenzhen Watmind Medical Co., Ltd.	Shenzhen Guangdong, CN
3002642396	Ortho Clinical Diagnostics	Singapore South West, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2020808. Last updated year: 2026. Please use registration number 2020808 when referencing this establishment in official correspondence.