FDA.reportPublic FDA data

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

Primary DI
00816068020825
Brand
Advanced Instruments Model 3250 Single-Sample Osmometer Sample Tubes, Box of 500
Company
ADVANCED INSTRUMENTS, INC.
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
New
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
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
125006353
Device count
500
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816068020566Advanced Instruments 30 µL Pipet2228202228202020-09-21
00816068020795Advanced Instruments OsmoPRO Multi Sample Micro Osmometer Sample Tubes2028252028252020-09-21
00816068020979Advanced Instruments 300 mOsm Calibration Std - 2mL Ampule - Pkg 103MA0033MA0032020-09-21
00816068020269Advanced Instruments Clinitrol 290 Reference Solution, 5mL Ampule, Pkg 103LA0293LA0292020-09-21
00816068020306Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 103MA2003MA2002020-09-21
00816068020313Advanced Instruments 50 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0053MA0052020-09-21
00816068020368Advanced Instruments Clinitrol 290 Reference Solution - 2mL Ampule - Pkg 103MA0293MA0292020-09-21
00816068020375Advanced Instruments 850 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0853MA0852020-09-21
00816068020436Advanced Instruments 100 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0113LA0112020-09-21
00816068020443Advanced Instruments 1500 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA1513LA1512020-09-21
00816068020450Advanced Instruments 500 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0513LA0512020-09-21
00816068020467Advanced Instruments 900 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0913LA0912020-09-21
00816068020474Advanced Instruments 2000 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA2013LA2012020-09-21
00816068020603Advanced Instruments A2O Advanced Automated Osmometer Samples Tubes, Box of 5002002232002232020-09-21
00816068020740Advanced Instruments 3000 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA3013LA3012020-09-21
00816068020757Advanced Instruments 0 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0003MA0002020-09-21
00816068020764Advanced Instruments 200 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0203MA0202020-09-21
00816068020771Advanced Instruments 400 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0403MA0402020-09-21
00816068020788Advanced Instruments 1000 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA1003MA1002020-09-21
00816068020993Advanced Instruments 4000 mOsm Calibration Std - 2mL Ampule - Pkg 103MA4003MA4002020-09-21

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