Advanced Instruments BR2 Disposable Cuvettes - For In Vitro Diagnostic Use. Advanced - ADVANCED INSTRUMENTS, INC.

Duns Number:125006353

Device Description: For In Vitro Diagnostic Use. Advanced Instruments Total Bilirubin Test Kit has been devel For In Vitro Diagnostic Use. Advanced Instruments Total Bilirubin Test Kit has been developed for use exclusively with the Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer. Contains one-hundred 4.5mL cuvettes.

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More Product Details

Catalog Number

B2A800

Brand Name

Advanced Instruments BR2 Disposable Cuvettes

Version/Model Number

B2A800

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)

Yes

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

CIG

Product Code Name

Diazo Colorimetry, Bilirubin

Device Record Status

Public Device Record Key

58b5f021-9928-4a2d-9f29-8267cec92272

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

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