DAVID - The convenience kit is consisiting of 30 - Runbio Biotech Co., Ltd.

Duns Number:545868502

Device Description: The convenience kit is consisiting of 30 ovulation test strips and 10 pregnancy test strip The convenience kit is consisiting of 30 ovulation test strips and 10 pregnancy test strips .

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More Product Details

Catalog Number

-

Brand Name

DAVID

Version/Model Number

82412

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

OIE

Product Code Name

Urine Collection Kit (Excludes Hiv Testing)

Device Record Status

Public Device Record Key

0b493654-8e4a-47e5-a362-cfc4261c7e6b

Public Version Date

May 04, 2021

Public Version Number

1

DI Record Publish Date

April 26, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RUNBIO BIOTECH CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 13
U Unclassified 1