CAROLINA LIQUID CHEMISTRIES CORP.™ OP OPIATES CC411A - OP (Opiates) CX/LX/DXC 1 x 250 tests - CAROLINA LIQUID CHEMISTRIES CORPORATION

Duns Number:962385787

Device Description: OP (Opiates) CX/LX/DXC 1 x 250 tests

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More Product Details

Catalog Number

CC411A

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.™ OP OPIATES CC411A

Version/Model Number

CC411A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 27, 2018

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DJG

Product Code Name

ENZYME IMMUNOASSAY, OPIATES

Device Record Status

Public Device Record Key

1be62860-913a-4858-9f1d-c7ee535f6389

Public Version Date

August 28, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAROLINA LIQUID CHEMISTRIES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 144
2 A medical device with a moderate to high risk that requires special controls. 183
U Unclassified 7