Facility

EPITOPE DIAGNOSTICS, INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst VAI

—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)	3004185580
Establishment type	Manufacture Medical Device
Location	17034 Camino San Bernardo SAN DIEGO, CA, US 92127
Registration status	Active · expires 2026
Parent company	EPITOPE DIAGNOSTICS, INC. (owner-operator 9059077)
Brand names	KT 876 EDI Total GLP-1 ELISA Kit; KTR 866 Serolisa Human ncFGF-21 ELISA Kit; KT 879 EDI Human Intact FGF-21 ELISA Kit; KTR 874 Serolisa Human cFGF-21 ELISA Kit; KT 871 EDI Active GLP-1 (7-36) Specific ELISA Kit; KT 602 EDI Human Total GLP-1 ELISA Kit; KTR 873 Serolisa Human nFGF-21 ELISA Kit; KT 878 EDI Rodent Active GLP-1 (7-36) Specific ELISA Kit; KT 800 EDI Human Fetuin-A ELISA Kit

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Reagents, Specific, Analyte
Product code MVU (opens in a new tab) · Class I · Pathology · 21 CFR 864.4020

Recalls & enforcement

Class IIOngoing2020-10-01
The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.

FDA inspections (1)

VAI2023-04-28
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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.

All facilities operated by EPITOPE DIAGNOSTICS, INC.

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. “EPITOPE DIAGNOSTICS, INC. (FEI 3004185580) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004185580-epitope-diagnostics-inc/

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