Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044854712

FEI Number

3044854712

Entity Name

BIO-GRAM DIAGNOSTICS GMBH

City/State/Country

Worms Rhineland-Palatinate, DE

Establishment Address

Altrheinstrasse 12, Worms Rhineland-Palatinate 67550, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bio-Gram Diagnostics GmbH (Owner Number: 10095760)

Owner / Operator Contact Address

Altrheinstrasse 12, Worms, DE-RP 67550, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gram-Polychrom JetDye-AF Kit Gram-Polychrom JetDye-AF System Kit Methyleneblue JetDye-AF Crystal-Violete JetDye-AF Safranin-FX JetDye-AF Lugols JetDye-AF MGG JetDye-AF Kit Wright JetDye-AF MGG JetDye-AF Wright-Giemsa JetDye-AF Wright-Giemsa JetDye-AF Kit Wright-Giemsa JetDye-AF System Kit JetBuffer pH 6.8 JaClean JetBuffer pH 6.4 Giemsa JetDye-AF JetBuffer pH 7.2 MGG JetDye-AF System Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2026-04-24
GJL	Romanowsky Stains	Hematology	Class 1	864.1850	2026-04-24

Official Correspondent

Bayram Cucu

US Agent Details

Adam Steadman Business: MDD Options, LLC Email: compliance@mddoptions.com Phone: (984) 3550399

Related Public Records

Same Entity

Bio-Gram Diagnostics GmbH

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-0025-05	Becton Dickinson & Co.	1	Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044854712. Last updated year: 2026. Please use registration number 3044854712 when referencing this establishment in official correspondence.