Rapid Response - Rapid Response 4 Parameter Urinalysis Reagent - BTNX Inc

Duns Number:251005005

Device Description: Rapid Response 4 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO) - 100 tests/ kit ar Rapid Response 4 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocytes, Protein in urine.

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More Product Details

Catalog Number

U4.1-1S100

Brand Name

Rapid Response

Version/Model Number

U4.1-1S100

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

K061559,K061559

Product Code Details

Product Code

JIL

Product Code Name

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Device Record Status

Public Device Record Key

a99cdfa8-fd55-40b0-bdac-a3142c3cc004

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

October 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BTNX INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 27