Advanced Instruments BR2 Hydrochloric Acid - 25mL bottle of Hydrochloric Acid - ADVANCED INSTRUMENTS, INC.

Duns Number:125006353

Device Description: 25mL bottle of Hydrochloric Acid

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More Product Details

Catalog Number

-

Brand Name

Advanced Instruments BR2 Hydrochloric Acid

Version/Model Number

B2A102Y

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

1b599df1-a3fd-42d2-8f23-388aa762fd9e

Public Version Date

March 29, 2018

Public Version Number

2

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