Facility

SD Biosensor, Inc.

2 recall(s) on record — most severe on record: Class I.

Key facts

2recalls · worst Class I

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008959428
Establishment type	Manufacture Medical Device
Location	74, Osongsaengmyeong 4-ro, Osong-eup Cheongju-si Chungbuk, KR 28161
Registration status	Active · expires 2026
Parent company	SD Biosensor, Inc. (owner-operator 10035779)
Brand names	Pilot COVID-19 At-Home Test; STANDARD COVID-19 Ag Control Swab; STANDARD Q COVID-19 Ag Test 2

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Coronavirus Antigen Detection Test System.
Product code QKP (opens in a new tab) · Not classified · Unknown

Recalls & enforcement

Class IOngoing2023-03-31
The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
Class IOngoing2022-01-31
Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

FDA inspections (1)

NAI2023-11-09
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SD Biosensor, Inc. (FEI 3008959428) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008959428-sd-biosensor-inc/

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