FDA.reportPublic FDA data

Advanced Instruments A2O System Fluid

Primary DI
00816068020634
Brand
Advanced Instruments A2O System Fluid
Company
Advanced Instruments, LLC
Model
200222
Catalog number
200222
Device description
A2O System Fluid is used for system cleaning during automated osmolality testing
Published
2020-09-21
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
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
00816068020634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816068020634008160680206348160680206340816068020634

GMDN Terms#

Term, Definition table
TermDefinition
Wash/cleaning solution IVD, automated/semi-automated systemA concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.

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
true
No natural rubber latex
false
Sterilization required before use
false

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
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
00816068020030Advanced Instruments BR2 Total Bilirubin Test Kit, Reagents, and CuvettesB2A101B2A1012016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850041049175Probe for Multi-OSMETTE Precision Systems, Inc.JJM2023-10-14
00850041049182Multi-OSMETTE, Extended Range, 220VPrecision Systems, Inc.JJM2023-10-14
00850041049199OSMETTE XL, 105VAC, JapanPrecision Systems, Inc.JJM2023-10-14
00850041049212OSMETTE Sample Tubes, 2 ml, 12/pkPrecision Systems, Inc.JJM2023-10-14
00850041049229OSMETTE Sample Tubes, 0.2 ml, 12/pkPrecision Systems, Inc.JJM2023-10-14
00850041049236Micro-OSMETTE Sample Tubes, 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049243OSMETTE XL, 105VAC, Japan, specialPrecision Systems, Inc.JJM2023-10-14
00850041049267OSMETTE Pipettor, 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049281Clearview Disp Sample Tubes, 0.2 mlPrecision Systems, Inc.JJM2023-10-14
00850041049311CRYETTE Stir Wires, for 2 ml tubes, 4/pkPrecision Systems, Inc.JJM2023-10-14
00850041049328OSMETTE Stir Wires, for 0.2 & 2.0 samples, 4/pkgPrecision Systems, Inc.JJM2023-10-14
00850041049335Micro-OSMETTE Stir Wires for 50 ul samples, 4/pkgPrecision Systems, Inc.JJM2023-10-14
00850041049366OSMETTE III 10 ul Pipet Piston 2/pkPrecision Systems, Inc.JJM2023-10-14
00850041049373OSMETTE III Plunger Tip WirePrecision Systems, Inc.JJM2023-10-14
00850041049380OSMETTE Sample Tubes, 30 ulPrecision Systems, Inc.JJM2023-10-14
00850041049410OSMETTE Sample Tube Rack for 2.0 & 0.2 mlPrecision Systems, Inc.JJM2023-10-14
00850041049427Multi-OSMETTE Carousel, SparePrecision Systems, Inc.JJM2023-10-14
00850041049434Multi-OSMETTE Evaporation ShieldPrecision Systems, Inc.JJM2023-10-14
00850041049441OSMETTE Sample Tube Rack, 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049489OSMETTE III Pipette Tips & CLEANETTEs, 1/M ea/pkPrecision Systems, Inc.JJM2023-10-14
00850041049502OSMETTE Probe 0.2 & 2.0 mlPrecision Systems, Inc.JJM2023-10-14
00850041049519Touch Micro-OSMETTE ProbePrecision Systems, Inc.JJM2023-10-14
00850041049526OSMETTE III ProbePrecision Systems, Inc.JJM2023-10-14
00850041049533OSMETTE Sample Tubes, 30 ulPrecision Systems, Inc.JJM2023-10-14
0085004104954010 ul Pipettor for OSMETTE IIIPrecision Systems, Inc.JJM2023-10-14
00850041049557OSMETTE Pipette Tips 1000/pkg 30 - 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049564OSMETTE Printer RibbonPrecision Systems, Inc.JJM2023-10-14
00850041049571OSMETTE Bath Liquid, 250mlPrecision Systems, Inc.JJM2023-10-14