SCANTIBODIES LABORATORY INC.

FDA Device Registration & Listing · San Diego, CA, US · Registration 3026664926

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3026664926
FEI Number
3026664926
Entity Name
SCANTIBODIES LABORATORY INC.
City/State/Country
San Diego, CA, US
Establishment Address
8005 Saint Andrews Ave, San Diego, CA 92154, 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
Y
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
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2021-12-06
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2023-01-19
GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C Microbiology Class 1 866.3330 2023-01-19
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2022-01-03
LQP Campylobacter Spp. Microbiology Class 1 866.3110 2022-02-02
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2020-11-18

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
3002792284 LABORATORIOS SCANTIBODIES S.A. DE C.V. TECATE Baja California, MX
3033507883 Laboratorios Scantibodies, S.A. de C.V. Tijuana Baja California, MX
2020808 SCANTIBODIES LABORATORY, INC. SANTEE, CA, US

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026664926. Last updated year: 2026. Please use registration number 3026664926 when referencing this establishment in official correspondence.
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