ORFILA DIAGNOSTICS INC. DBA NFORM

FDA Device Registration & Listing · Wilmington, DE, US · Registration 3027693054

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
3027693054
FEI Number
3027693054
Entity Name
ORFILA DIAGNOSTICS INC. DBA NFORM
City/State/Country
Wilmington, DE, US
Establishment Address
401 Marsh Ln, Wilmington, DE 19804, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Orfila Diagnostics Inc. dba nform (Owner Number: 10092437)
Owner / Operator Contact Address
401 East Marsh Lane, Newport, DE 19804, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

nform THC nform COMBO Oral Fluid Rapid Drug Test nform 7 Oral Fluid Rapid Drug Test nform 7 Oral Fluid Rapid Drug Tests nform COMBO Oral Fluid Rapid Drug Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PVJ Test, Cannabinoid, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3870 2025-02-11
PUX Test, Amphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3100 2025-12-08
PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3250 2025-12-08

Official Correspondent

Michael Vincent

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Orfila Diagnostics Inc. dba nform
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027693054. Last updated year: 2026. Please use registration number 3027693054 when referencing this establishment in official correspondence.
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