Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1834174

FEI Number

1000160375

Entity Name

BCD AND ASSOCIATES

City/State/Country

Indianapolis, IN, US

Establishment Address

8904 Bash Street, Suite M, Indianapolis, IN 46256, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BCD AND ASSOCIATES (Owner Number: 9008625)

Owner / Operator Contact Address

8904 Bash Street, Suite M, Indianapolis, IN 46256, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sensi-Disc Dispenser, Single Sensi-Disc Dispenser, 6-Place Sensi-Disc Dispenser, 8-Place Sensi-Disc Dispenser, 12-Place

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2013-01-29

Official Correspondent

DUANE DURKOS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BCD AND ASSOCIATES

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1834174. Last updated year: 2026. Please use registration number 1834174 when referencing this establishment in official correspondence.