Facility

IMMUNDIAGNOSTIK, INC.

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3015189693
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	150 Dow Street Manchester, NH, US 03101
Registration status	Active · expires 2026
Parent company	Immundiagnostik, Inc. (owner-operator 10059103)
Brand names	IDK® Pancreatic Elastase ELISA

Activity by year

Recalls (1)

Devices registered here (1)

P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin
Product code JNN (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1725

Recalls & enforcement

Class IICompleted2023-03-27
Marketed without a 510k

All facilities operated by Immundiagnostik, 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. “IMMUNDIAGNOSTIK, INC. (FEI 3015189693) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015189693-immundiagnostik-inc/

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