Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2432495

FEI Number

2432495

Entity Name

BIOCHEMICAL DIAGNOSTICS, INC.

City/State/Country

Edgewood, NY, US

Establishment Address

180 HEARTLAND BLVD., Edgewood, NY 11717, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

BIOCHEMICAL DIAGNOSTICS, INC. (Owner Number: 2432495)

Owner / Operator Contact Address

37 Birch Street, --, Milford, MA 01757, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153474

PMA Number

N/A

All Registered Proprietary Names

DETECTABUSE PREGNANCY-SKREEN Detectabuse Liquid Control Salivabuse Liquid Oral Fluid Control Kova POC Pregnancy-Skreen hCG Serum Detectabuse STAT-SKREEN-H STAT-SKREEN-H with MDMA, OXY & BUP STAT-SKREEN DOA-SKREEN-H STAT-SKREEN 17H STAT-SKREEN 17 DOA-SKREEN STAT-SKREEN with MDMA, OXY & BUP AU/NZ SKREEN Fentanyl 2x5mL kitbox AU NZ SKREEN23 STAT-SKREEN25H STAT-SKREEN 23, STAT-SKREEN 23H Toxicology Evaluation Panel II STAT-SKREEN25 AU/NZ SKREEN23

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2020-08-06
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2007-11-01
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-11-01
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2012-10-03
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2014-11-05
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2021-08-10
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2016-10-13

Official Correspondent

David Larrivee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOCHEMICAL DIAGNOSTICS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K803039	General Diagnostics	PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.	1980-12-22
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

Similar Registrations

Registration Number	Establishment Name	Location
8043909	WALLAC OY	TURKU Varsinais-Suomi, FI
3008156187	TECHNO-PATH MANUFACTURING LTD.	Ballina Tipperary, IE
2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	RARITAN, NJ, US
3021090658	Ortho-Clinical Diagnostics, Inc.	Carlsbad, CA, US
2026994	INOVA DIAGNOSTICS, INC.	SAN DIEGO, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2432495. Last updated year: 2026. Please use registration number 2432495 when referencing this establishment in official correspondence.