FDA.reportPublic FDA data

Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit

Primary DI
00816068020856
Brand
Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit
Company
Advanced Instruments, LLC
Model
111280
Catalog number
111280
Device description
Multilevel control that provides a means of measuring and verifying the performance of the GloCyte Cell counter for CSF for total nucleated and red blood cells.
Published
2020-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JPKMixture, Hematology Quality Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPKMixture, Hematology Quality ControlHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816068020856PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816068020856008160680208568160680208560816068020856

GMDN Terms#

Term, Definition table
TermDefinition
White blood cell count IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen.

Contacts#

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

Regulatory Flags#

DUNS number
125006353
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10816068020211Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit1110111110112016-09-23
00816068020535Advanced Instruments RBC Reagent Filtration Kit1110141110142021-05-21
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

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