Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009000266

FEI Number

3009000266

Entity Name

RAL DIAGNOSTICS

City/State/Country

Martillac Gironde, FR

Establishment Address

Site Montesquieu 2 Rue Jacques Monod, Martillac Gironde 33650, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ral Diagnostics (Owner Number: 10079788)

Owner / Operator Contact Address

Site Montesquieu 2 Rue Jacques Monod, Martillac, FR-33 33650, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

360210-0000 Kit RAL Stainer Gram-Hucker 360220-0000 Kit RAL Stainer Gram-Nicolle RAL Diff-Quik EZ-Kit (3x100ml) 360200-0000 Kit RAL Stainer MCDh RAL Diff-Quik Solution I (1x2, 5L) RAL Diff-Quik Kit (3x500ml) RAL Diff-Quik Solution II (1x2, 5L) Kit StainBox BBM Kit StainBox MCDh Kit RAL Stainer MCDh RAL Diff-Quik Fixative Solution (1x2, 5L) MCDh Zero S1 for SP Automated Systems MCDh Zero S4 for SP Automated Systems MCDh Zero S3 for SP Automated Systems MCDh Zero S2 for SP Automated Systems Pack Immersion 150 Dropstand with Dropstick RAL Pack Immersion 300 405000 RAL Stainer Blue-Ral 555 Fix-Ral 555 Eosine-Ral 555

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2020-12-23
KQC	Stains, Hematology	Hematology	Class 1	864.1850	2020-12-23
IJZ	Oil, Clearing	Pathology	Class 1	864.4010	2020-12-23
KIO	Slide Stainer, Immersion Type	Pathology	Class 1	864.3800	2020-12-23
GJL	Romanowsky Stains	Hematology	Class 1	864.1850	2020-12-23

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Ral Diagnostics

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
K791007	Bioscientific	STAT DIFF STAIN	1979-08-03

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.
Z-0043-2012	EMD Chemicals Inc.	1	Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009000266. Last updated year: 2026. Please use registration number 3009000266 when referencing this establishment in official correspondence.