CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT CC621 - Lipase Reagent (LIP) w/ Calibrator - CAROLINA LIQUID CHEMISTRIES CORPORATION

Duns Number:962385787

Device Description: Lipase Reagent (LIP) w/ Calibrator

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More Product Details

Catalog Number

CC621

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT CC621

Version/Model Number

CC621

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

-

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

CHI

Product Code Name

LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

Device Record Status

Public Device Record Key

173621f5-dcec-4f7b-ac51-4efc1e88a4ab

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

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