MedtechSourcebook

Coronavirus Antigen Detection Test System. (QKP) contract manufacturers

6 US facilities list FDA product code QKP as a contract manufacturer (6) or contract sterilizer (0).

FDA-registered (openFDA, export of Oct 21, 2026)

FDA device name
Coronavirus Antigen Detection Test System.
Product code
QKP (FDA product classification database)
Device class
Not classified
Classification panel
Microbiology

Where they are

California 5 ยท Pennsylvania 1

All 6 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
AZER SCIENTIFIC, INC.3009963993Contract manufacturerHematology; Pathology; MicrobiologyMorgantown, PANot verifiedOct 21, 2026
BREATHH INC3017171515Contract manufacturerGeneral hospital; MicrobiologySan Diego, CANot verifiedOct 21, 2026
iHealth Manufacturing Inc3023947183Contract manufacturerMicrobiologyIrwindale, CANot verifiedOct 21, 2026
SCANTIBODIES LABORATORY INC.3026664926Contract manufacturerMicrobiology; General hospital; PathologySan Diego, CANot verifiedOct 21, 2026
SCANTIBODIES LABORATORY, INC.2020808Contract manufacturerMicrobiologySantee, CANot verifiedOct 21, 2026
TRUE DIAGNOSTICS, INC.3027500452Contract manufacturerClinical chemistry; General hospital; MicrobiologyCarlsbad, CANot verifiedOct 21, 2026

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