Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1550222

FEI Number

1550222

Entity Name

VWR CHEMICALS, LLC

City/State/Country

Solon, OH, US

Establishment Address

28600 Fountain Pkwy, Solon, OH 44139, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

VWR INTERNATIONAL, LLC (Owner Number: 9009749)

Owner / Operator Contact Address

100 Matsonford Road, Building One, Suite 200, Radnor, PA 19087, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Solution E, PRTM Buffer, Phosphate Buffered Saline (PBS), Decellularizing Solution, C-L-P-V Supplement, LTM DNASE Buffer Strattice Reconstructive Tissue Matrix (RTM), Strattice (RTM) Extra Thick, Strattice (RTM) Perforated, Atria (RTM), Strattice and Alloderm XPERT MRSA Elution Reagent, Assay Lysis buffer Wash Buffer 2 Wash Buffer 1 Ictotest Reagent Tablets for Urinalysis Ictotest Test for Urinary Bilirubin Guanidine Thiocyanate, 4.8M DNA STABILIZATION BUFFER AMMONIUM BISULFITE, 68% GUANIDINE HYDROCHLORIDE, 7M INHIBITOR REMOVAL TABLETS BD Viper System Neutralization Pouch Protease Buffer Vysis Pretreatment Solution 1N NaSCN 50mL Vysis Paraffin Pretreatment Reagent Kit Vysis Fish Pre-Treatment Reagent Kit bcr/abl1 Monitoring Test ASSY, RGT, Set, PK, HEMONC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2021-12-03
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	Class 2	866.1640	2021-12-03
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2019-04-19
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2019-04-19
PHP	System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection	Unknown	Class 3	N/A	2020-11-18
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2021-12-03
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2019-04-19
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2023-12-13
OYX	Bcr/Abl1 Monitoring Test	Medical Genetics	Class 2	866.6060	2023-12-13

Official Correspondent

Aubrey Buenger

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VWR INTERNATIONAL, 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
3015267208	Ward's Science, Division of VWR International LLC	Greece, NY, US
1313870	Ward's Science, a division of VWR International, LLC	W Henrietta, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2020	AZIYO BIOLOGICS	2	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020	AZIYO BIOLOGICS	2	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1550222. Last updated year: 2026. Please use registration number 1550222 when referencing this establishment in official correspondence.