FDA.reportPublic FDA data

Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 10

Primary DI
10816068020303
Brand
Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 10
Company
Advanced Instruments, LLC
Model
3MA200
Catalog number
3MA200
Device description
Calibration standards are used to calibrate and/or check the performance of customer osmometers.
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
10816068020303PrimaryGS10
00816068020306Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081606802030310816068020303
00816068020306008160680203068160680203060816068020306

GMDN Terms#

Term, Definition table
TermDefinition
Osmolality IVD, calibratorA material which is used to establish known points of reference for 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

Contacts#

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

Regulatory Flags#

DUNS number
125006353
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00816068020917Advanced Instruments Ergonomic Culture Jar, SmallAJ9049AJ90492020-09-21
00816068020924Advanced Instruments Ergonomic Culture Jar, LargeAJ9050AJ90502020-09-21
00816068020948Advanced Instruments Standard Anoxomat Jar, MediumAJ9025AJ90252020-09-21
00816068020955Advanced Instruments Standard Anoxomat Jar, LargeAJ9028AJ90282020-09-21
00816068020962Advanced Instruments Palladox Disposable SatchetAN3146AN31462020-09-21
00816068020023Advanced Instruments BR2 Disposable CuvettesB2A800B2A8002016-09-23
00816068020030Advanced Instruments BR2 Total Bilirubin Test Kit, Reagents, and CuvettesB2A101B2A1012016-09-23
00816068020047Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and CuvettesB2A102B2A1022016-09-23
00816068020054Advanced Instruments BR2 Bilirubin Stat-AnalyzerBR2BR22016-09-23
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
00816068020535Advanced Instruments RBC Reagent Filtration Kit1110141110142021-05-21
00816068020856Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit1112801112802020-07-21

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
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
10816068020457Advanced Instruments 500 mOsm Calibration Standard - 5mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21