FDA.reportPublic FDA data

Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10

Primary DI
00816068020481
Brand
Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10
Company
Advanced Instruments, LLC
Model
3LA028
Catalog number
3LA028
Device description
The Osmolality Linearity Set is designed to help clinical laboratories easily monitor osmometer performance specifications and fulfill CLIA requirements for verifying the reportable range of a laboratory method.
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
JMZComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMZComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, OsmolalityClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816068020481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816068020481008160680204818160680204810816068020481

GMDN Terms#

Term, Definition table
TermDefinition
Osmolality IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of osmolality of a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
125006353
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816068020266Advanced Instruments Clinitrol 290 Reference Solution, 5mL Ampule, Pkg 103LA0293LA0292020-09-21
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
10816068020747Advanced Instruments 3000 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA3013LA3012020-09-21
10816068020754Advanced Instruments 0 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0003MA0002020-09-21
00816068020832Advanced Instruments Model 3250 Single-Sample Osmometer Sample Tubes, Box of 5003LA8253LA8252020-09-21
00816068020504Advanced Instruments Ease-Eject 20-Microliter Sampler3M08253M08252020-09-21
00816068020580Advanced Instruments 2020 Osmometer Probe Wiper Rings2028402028402020-09-21
00816068020597Advanced Instruments 20 µL Pipet2408202408202020-09-21
00816068020610Advanced Instruments A2O Osmometer Probe Wiper Rings2002212002212020-09-21
00816068020627Advanced Instruments Cuvettes2002202002202020-09-21
00816068020634Advanced Instruments A2O System Fluid2002222002222020-09-21
00816068020658Advanced Instruments Swab Cleaners2028502028502020-09-21
00816068020719Advanced Instruments 500 mOsm Calibration Standard - 110 mL Bottle3LA0503LA0502020-09-21
00816068020726Advanced Instruments 900 mOsm Calibration Standard - 110 mL Bottle3LA0903LA0902020-09-21
00816068020733Advanced Instruments 1500 mOsm Calibration Standard - 110 mL Bottle3LA1503LA1502020-09-21
00816068020023Advanced Instruments BR2 Disposable CuvettesB2A800B2A8002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850041049014Precision Systems 100 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049021Precision Systems 200 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049038Precision Systems 300 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049045Precision Systems 400 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049052Precision Systems 500 mOsm Osmometry Standard, 125 mL bottlePrecision Systems, Inc.JMZ2023-10-14
00850041049069Precision Systems 600 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049076Precision Systems 700 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049083Precision Systems 800 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049090Precision Systems 900 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049106Precision Systems 1000 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049113Precision Systems 1100 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049120Precision Systems 1200 mOsm Osmometry Standard, 250 mL bottlePrecision Systems, Inc.JMZ2023-10-14
00850041049137Precision Systems 1300 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049151Precision Systems 1500 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049205Precision Systems 2000 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049250Precision Systems 2500 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049304Precision Systems 3000 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049588Precision Systems CON-TROL 100, 5 ml ampules, 12/pkPrecision Systems, Inc.JMZ2023-10-14
00850041049595Precision Systems CON-TROL 290, 5 ml ampules, 12/pkPrecision Systems, Inc.JMZ2023-10-14
00850041049601Precision Systems CON-TROL 500, 5 ml ampules, 12/pkPrecision Systems, Inc.JMZ2023-10-14
00850041049618Precision Systems CON-TROL 1500, 5 ml ampules, 12/pkPrecision Systems, Inc.JMZ2023-10-14
00850041049625Precision Systems CON-TROL Cal Pack, 4 each: 100, 500 & 1500 mOsm 5 ml ampulesPrecision Systems, Inc.JMZ2023-10-14
00850041049007Precision Systems 0 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-09-29
10816068020266Advanced Instruments Clinitrol 290 Reference Solution, 5mL Ampule, Pkg 10Advanced Instruments, LLCJMZ2020-09-21
10816068020303Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21
10816068020310Advanced Instruments 50 mOsm Calibration Standard - 2mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21
10816068020365Advanced Instruments Clinitrol 290 Reference Solution - 2mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21
10816068020372Advanced Instruments 850 mOsm Calibration Standard - 2mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21
10816068020433Advanced Instruments 100 mOsm Calibration Standard - 5mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21
10816068020440Advanced Instruments 1500 mOsm Calibration Standard - 5mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21