Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2518630

FEI Number

2518630

Entity Name

BIO-TEST MEDICAL, INC.

City/State/Country

GIBSONIA, PA, US

Establishment Address

3503 Gibsonia Rd, GIBSONIA, PA 15044, US

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BIO-TEST MEDICAL, INC. (Owner Number: 2518630)

Owner / Operator Contact Address

3503 Gibsonia Rd.., --, Gibsonia, PA 15044, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gram Stain Control

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JTR	Kit, Quality Control For Culture Media	Microbiology	Class 1	866.2480	1992-07-30

Official Correspondent

CARMEN D'AMBROSIO, JR.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIO-TEST MEDICAL, INC.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2518630. Last updated year: 2026. Please use registration number 2518630 when referencing this establishment in official correspondence.