NA - Liquid Urine Control - Level 1, 10 ml. 18 month - ALTA DIAGNOSTICS INC

Duns Number:859323297

Device Description: Liquid Urine Control - Level 1, 10 ml. 18 month open vial stability when stored at 2-8° C.

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More Product Details

Catalog Number

323-16-1

Brand Name

NA

Version/Model Number

323-16-1

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

K890577,K890577

Product Code Details

Product Code

JJW

Product Code Name

Urinalysis Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

f53c4eee-a9cf-4801-9557-b1f12eb16d82

Public Version Date

April 08, 2019

Public Version Number

1

DI Record Publish Date

March 29, 2019

Additional Identifiers

Package DI Number

30858512007083

Quantity per Package

6

Contains DI Package

10858512007089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ALTA DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19