AVANTOR PERFORMANCE MATERIALS, LLC

FDA Device Registration & Listing · Paris, KY, US · Registration 1045125

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1045125
FEI Number
1045125
Entity Name
AVANTOR PERFORMANCE MATERIALS, LLC
City/State/Country
Paris, KY, US
Establishment Address
7001 MARTIN LUTHER KING JR BLVD, Paris, KY 40361, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
AVANTOR PERFORMANCE MATERIALS, LLC (Owner Number: 9003640)
Owner / Operator Contact Address
100 Matsonford Road, Suite 200, Radnor, PA 19087, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SUDAN IV SOLUTION ACID CONTAINING DECALCIFIER AURAMINE O ANILINE BLUE/WS PHLOXINE B EOSIN B NEUTRAL RED CERTIFIED OR NEUTRAL RED CERTIFED OR GIEMSA STAIN CERTIFIED OR GIEMSA STAIN FORMALDEHYDE SOLUTION, 10% (W/V) IN AQUEOUS PHOSPHATE BUFFER EOSIN Y CERTIFIED OR EOSIN Y CERTIFIED OR SCHIFF REAGENT COLLODION, FLEXIBLE COLLODION Phosphate Buffer, M/15, pH 6.8 ROSE BENGAL SAFRANIN O WRIHT STAIN CERTIFIED OR WRIGHT STAIN CERTIFIED OR XYLENES HISTOLOGY XYLENES REAGENT XYLENES BISMARCK BROWN Y METHYLENE BLUE METHYLENE BLUE N BRECHER HEMATOXYLIN CERTIFIED OR MALACHITE GREEN OX GENTIAN VIOLET CRYSTAL VIOLET FOR HISTOLOGY BASIC FUCHSIN HYDROCHLORIDE ACID FUCHSIN

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KKK Sudan Iv Hematology Class 1 864.1850 2007-08-29
KDX Solution, Decalcifier, Acid Containing Pathology Class 1 864.4010 2007-08-29
KJK Auramine O Hematology Class 1 864.1850 2007-08-29
KFD Aniline Blue Hematology Class 1 864.1850 2007-08-29
HZL Phloxine B Hematology Class 1 864.1850 2007-08-29
ICC Eosin B Hematology Class 1 864.1850 2007-08-29
KFE Neutral Red Hematology Class 1 864.1850 1992-07-23
HYF Giemsa Stain Hematology Class 1 864.1850 2007-04-17
IGG Formaldehyde (Formalin, Formol) Pathology Class 1 864.4010 2007-08-29
HYB Eosin Y Hematology Class 1 864.1850 1992-07-23
HZT Reagent, Schiff Hematology Class 1 864.1850 2007-08-29
IAW Collodion Pathology Class 1 864.4010 1992-07-23
KQC Stains, Hematology Hematology Class 1 864.1850 2008-12-10
KKI Rose Bengal Hematology Class 1 864.1850 2007-08-29
HZS Safranin Hematology Class 1 864.1850 2007-08-29
IAF Wright'S Stain Hematology Class 1 864.1850 1992-07-23
KEM Agent, Clearing Pathology Class 1 864.4010 2021-12-13
KJM Bismarck Brown Y Hematology Class 1 864.1850 2011-09-15
KFC Methylene Blue, Tissue Stain Hematology Class 1 864.1850 2007-08-29
HYJ Hematoxylin Hematology Class 1 864.1850 1992-07-23
KJY Malachite Green Hematology Class 1 864.1850 1992-07-23
ICF Crystal Violet For Histology Hematology Class 1 864.1850 2007-08-29
KKW Basic Fuchsin Hematology Class 1 864.1850 2007-08-29

Official Correspondent

Aubrey Buenger

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AVANTOR PERFORMANCE MATERIALS, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3011558129 Avantor Performance Materials Poland S.A. Gliwice Slaskie, PL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K821443 Lerner Laboratories, Inc. FORMICAL 1982-06-02
K791007 Bioscientific STAT DIFF STAIN 1979-08-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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 1045125. Last updated year: 2026. Please use registration number 1045125 when referencing this establishment in official correspondence.
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