FDA.reportPublic FDA data

Advanced Instruments Model 3250 Single-Sample Osmometer Sample Tubes, Box of 500

Primary DI
00816068020832
Brand
Advanced Instruments Model 3250 Single-Sample Osmometer Sample Tubes, Box of 500
Company
Advanced Instruments, LLC
Model
3LA825
Catalog number
3LA825
Device description
Sample tubes for use with the Model 3250 Single-Sample Osmometer
Published
2020-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJMOsmometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJMOsmometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816068020832PrimaryGS10
00816068020825Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816068020832008160680208328160680208320816068020832
00816068020825008160680208258160680208250816068020825

GMDN Terms#

Term, Definition table
TermDefinition
Osmolality IVD, kit, freezing pointA collection of reagents and other associated materials intended to be used for the quantitative measurement of osmolality of a clinical specimen, using a freezing point method.

Contacts#

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

Regulatory Flags#

DUNS number
125006353
Device count
500
Premarket exempt
true
Lot or batch
true

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
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

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