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Advanced Instruments GloCyte® Automated Cell Counter System

Primary DI
00816068020139
Brand
Advanced Instruments GloCyte® Automated Cell Counter System
Company
Advanced Instruments, LLC
Model
GloCyte
Catalog number
GloCyte
Device description
For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients. Includes GloCyte instrument, computer, vacuum station, barcode reader, sample preparation tray, pipettes, and startup kit.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKLCounter, Cell, Automated (Particle Counter)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKLCounter, Cell, Automated (Particle Counter)Hematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816068020139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816068020139008160680201398160680201390816068020139

GMDN Terms#

Term, Definition table
TermDefinition
Haematological cell analyser IVD, automatedAn electrically-powered laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+17813209000Orders@aicompanies.com

Regulatory Flags#

DUNS number
125006353
Device count
1
Kit
true

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00816068020924Advanced Instruments Ergonomic Culture Jar, LargeAJ9050AJ90502020-09-21
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00816068020962Advanced Instruments Palladox Disposable SatchetAN3146AN31462020-09-21
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00816068020047Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and CuvettesB2A102B2A1022016-09-23
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00816068020078Advanced Instruments BR2 Sample DiluentB2A101D2016-09-23
00816068020085Advanced Instruments BR2 20 mg/dL Bilirubin Equivalent SolutionB2A101H2016-09-23
00816068020092Advanced Instruments BR2 5mg/dL Bilirubin Equivalent SolutionB2A101L2016-09-23
00816068020108Advanced Instruments BR2 Sodium NitriteB2A102N2016-09-23
00816068020115Advanced Instruments BR2 Sulfanilic AcidB2A102S2016-09-23
00816068020122Advanced Instruments BR2 Hydrochloric AcidB2A102Y2016-09-23
10816068020174Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene8000978000972016-09-23
10816068020211Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit1110111110112016-09-23
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Primary DI, Brand, Company table
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00630414222905ADVIA 120/2120/2120i® autoRETICSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222912ADVIA 120/2120/2120i® AUTOreticSiemens Healthcare Diagnostics Inc.GKL2016-09-24
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