Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10 - The Osmolality Linearity Set is designed to help - ADVANCED INSTRUMENTS, INC.

Duns Number:125006353

Device Description: The Osmolality Linearity Set is designed to help clinical laboratories easily monitor osmo 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.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

3LA028

Brand Name

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

Version/Model Number

3LA028

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JMZ

Product Code Name

Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality

Device Record Status

Public Device Record Key

32c91c49-d1c0-44e8-97b7-484310d41dd5

Public Version Date

September 29, 2020

Public Version Number

1

DI Record Publish Date

September 21, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADVANCED INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 50
2 A medical device with a moderate to high risk that requires special controls. 21