Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2244900

FEI Number

2244900

Entity Name

GLOBE SCIENTIFIC, LLC

City/State/Country

Mahwah, NJ, US

Establishment Address

400 CORPORATE DRIVE, Mahwah, NJ 07430, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

GLOBE SCIENTIFIC, INC. (Owner Number: 2244900)

Owner / Operator Contact Address

400 CORPORATE DRIVE, --, Mahwah, NJ 07430, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Globe Brand Globe Brand Globe Brand Container, Specimen SLIDES MICROSCOPE~PATHOLOGY Globe Brand Pap-test Cervical Spatula Cervical Scraper Globe Brand LABORATORY DISPOSABLES Globe Brand Globe Brand Globe Brand Globe Brand Globe Brand Cuvettes Sample Cups SPECIMEN~GENERAL HOSPITAL Globe Brand Globe Brand Globe Brand Transfer Syringe Inoculation Loops, Microbiology TISSUE~PATHOLOGY CASSETTES Globe Brand Absorbent Tipped Applicator PASTEUR~HEMATOLOGY PIPETTE Globe Brand Globe Brand Hematocrit Centrifuges Globe Brand

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGY	Pipette, Diluting	Hematology	Class 1	864.6160	2011-03-10
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2011-03-10
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2012-02-15
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2019-03-12
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2003-02-12
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2002-09-11
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2015-12-02
IGG	Formaldehyde (Formalin, Formol)	Pathology	Class 1	864.4010	2011-03-10
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2005-09-21
JRJ	Unit, Drying	Clinical Chemistry	Class 1	862.2050	2011-03-10
KDW	Container, Specimen Mailer And Storage, Temperature Controlled, Sterile	Pathology	Class 1	864.3250	2011-03-10
JRB	Micro Mixer	Clinical Chemistry	Class 1	862.2050	2011-09-15
KDX	Solution, Decalcifier, Acid Containing	Pathology	Class 1	864.4010	2011-03-10
JJG	Analyzer, Chemistry, Centrifugal, For Clinical Use	Clinical Chemistry	Class 1	862.2140	2002-09-11
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2003-02-12
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2011-03-10
JRQ	Shaker/Stirrer	Clinical Chemistry	Class 1	862.2050	2011-03-10
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2011-03-10
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-24
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2019-08-29
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	Class 1	866.2660	2019-03-12
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2003-02-12
IFP	Formalin, Neutral Buffered	Pathology	Class 1	864.4010	2011-03-10
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2020-01-24
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-03-19
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2019-07-11
GJW	Pipette, Pasteur	Hematology	Class 1	864.6160	2003-02-12
GLE	Mixer, Blood Tube	Clinical Chemistry	Class 1	862.2050	2011-09-15
KJG	Tube, Tissue Culture	Pathology	Class 1	864.3010	2011-03-10
GKG	Centrifuge, Hematocrit	Hematology	Class 2	864.6400	2019-07-11
MPQ	Container, Specimen, Urine, Drugs Of Abuse, Over The Counter	Pathology	Class 1	864.3260	2011-03-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GLOBE SCIENTIFIC, INC.

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
K913967	Doxtech, Inc.	DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM	1991-10-18
K821443	Lerner Laboratories, Inc.	FORMICAL	1982-06-02
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2020	Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands	1	V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2244900. Last updated year: 2026. Please use registration number 2244900 when referencing this establishment in official correspondence.