Ricca Chemical Company® - Exton Qualitative Reagent, for the Qualitative - Ricca Chemical Company, LLC

Duns Number:020335667

Device Description: Exton Qualitative Reagent, for the Qualitative Detection of Albumin in Urine

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More Product Details

Catalog Number

2950

Brand Name

Ricca Chemical Company®

Version/Model Number

2950-32

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)

-

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

JIQ

Product Code Name

TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

Device Record Status

Public Device Record Key

f4ad89bd-b3c7-4e6c-acef-c4063e4a172b

Public Version Date

February 12, 2021

Public Version Number

1

DI Record Publish Date

February 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RICCA CHEMICAL COMPANY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23