FDA.reportPublic FDA data

Advanced Instruments A2O Advanced Automated Osmometer Samples Tubes, Box of 500

Primary DI
10816068020600
Brand
Advanced Instruments A2O Advanced Automated Osmometer Samples Tubes, Box of 500
Company
Advanced Instruments, LLC
Model
200223
Catalog number
200223
Device description
Sample tubes for use with the A2O Advanced Automated 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
10816068020600PrimaryGS10
00816068020603Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081606802060010816068020600
00816068020603008160680206038160680206030816068020603

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
00816068020900Advanced Instruments Anoxomat III Anaerobic Culture System (100V - 120V)Anoxomat III (100V - 120V)Anoxomat III (100V - 120V)2020-09-21
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

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Primary DI, Brand, Company table
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00850041049434Multi-OSMETTE Evaporation ShieldPrecision Systems, Inc.JJM2023-10-14
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