FDA.reportPublic FDA data

Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit

Primary DI
10816068020211
Brand
Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit
Company
Advanced Instruments, LLC
Model
111011
Catalog number
111011
Device description
The GloCyte Red Blood Cell (RBC) Reagent is a non-automated in-vitro diagnostic device intended to stain erythrocytes for quantitative enumeration of RBCs in human cerebrospinal fluid (CSF) specimens collected from adult and pediatric patients. The reagent is intended to be used by trained healthcare professionals in clinical laboratories as an aid in diagnosis for neurological diseases such as a meningeal infection, subarachnoid hemorrhage, central nervous system malignancy, and demyelinating disease. For use on the GloCyte Automated Cell Counter System only.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152776000Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.2016-05-27GKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816068020211PrimaryGS10
00816068020214Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081606802021110816068020211
00816068020214008160680202148160680202140816068020214

GMDN Terms#

Term, Definition table
TermDefinition
Red cell antibody eluting IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in the process of eluting antibodies bound to antigens present on the surface of red blood cells of a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1-781-894-0800info@novabio.com

Regulatory Flags#

DUNS number
125006353
Device count
3
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816068020174Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene8000978000972016-09-23
00816068020535Advanced Instruments RBC Reagent Filtration Kit1110141110142021-05-21
00816068020856Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit1112801112802020-07-21
20816068020201Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays1110101110102016-09-23
00816068020009Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume8060548060542016-09-23
00816068020016Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume8060538060532016-09-23
00816068020153Advanced Instruments GloCyte® Vacuum Preparation Station Assembly1110761110762016-09-23
00816068020238Advanced Instruments GloCyte® Controls Kit1110131110132016-09-23
00816068020245Advanced Instruments GloCyte® Count Template Cartridge1111531111532016-09-23
10816068020266Advanced Instruments Clinitrol 290 Reference Solution, 5mL Ampule, Pkg 103LA0293LA0292020-09-21
10816068020303Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 103MA2003MA2002020-09-21
10816068020310Advanced Instruments 50 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0053MA0052020-09-21
10816068020365Advanced Instruments Clinitrol 290 Reference Solution - 2mL Ampule - Pkg 103MA0293MA0292020-09-21
10816068020372Advanced Instruments 850 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0853MA0852020-09-21
10816068020433Advanced Instruments 100 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0113LA0112020-09-21
10816068020440Advanced Instruments 1500 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA1513LA1512020-09-21
10816068020457Advanced Instruments 500 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0513LA0512020-09-21
10816068020464Advanced Instruments 900 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0913LA0912020-09-21
10816068020471Advanced Instruments 2000 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA2013LA2012020-09-21
10816068020600Advanced Instruments A2O Advanced Automated Osmometer Samples Tubes, Box of 5002002232002232020-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816068020535Advanced Instruments RBC Reagent Filtration KitAdvanced Instruments, LLCGKL2021-05-21
00858604006108IVOSHAMILTON THORNE, INC.GKL2019-11-30
00858604006719CEROSHAMILTON THORNE, INC.GKL2019-11-30
00630414222882ADVIA® 120/2120/2120i CBC TIMEpacSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222899ADVIA 120/2120/2120i® DIFF TIMEpacSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222905ADVIA 120/2120/2120i® autoRETICSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222912ADVIA 120/2120/2120i® AUTOreticSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222929ADVIA 120/2120/2120i® Sheath/RinseSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222943ADVIA 120/2120/2120i® DefoamerSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222950ADVIA 120/2120/2120i® CN-FREE CBC TIMEPACSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414223032ADVIA 120/2120/2120i® Sheath/RinseSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414224305ADVIA 120/2120/2120i® OPTIpointSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414224329ADVIA 120/2120/2120i® OPTIpointSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414473383ADVIA 120/2120/2120i® Perox SheathSiemens Healthcare Diagnostics Inc.GKL2016-09-24
10816068020174Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL PolypropyleneAdvanced Instruments, LLCGKL2016-09-23
10816068020228Advanced Instruments GloCyte® Total Nucleated Cell Test Reagent KitAdvanced Instruments, LLCGKL2016-09-23
10816068020204Advanced Instruments GloCyte® Test Cartridge & Tray - 25 CartridgesAdvanced Instruments, LLCGKL2016-09-23
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20816068020201Advanced Instruments GloCyte® Test Cartridge Kit - 8 TraysAdvanced Instruments, LLCGKL2016-09-23
00816068020009Advanced Instruments GloCyte® Pipette, 30µL Fixed VolumeAdvanced Instruments, LLCGKL2016-09-23
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00816068020146Advanced Instruments GloCyte® Instrument AssemblyAdvanced Instruments, LLCGKL2016-09-23
00816068020153Advanced Instruments GloCyte® Vacuum Preparation Station AssemblyAdvanced Instruments, LLCGKL2016-09-23
00816068020245Advanced Instruments GloCyte® Count Template CartridgeAdvanced Instruments, LLCGKL2016-09-23
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