ChoiceMMed - One Step HCG Urine Pregnancy Test Strip - Beijing Choice Electronic Technology Co., Ltd.

Duns Number:526882823

Device Description: One Step HCG Urine Pregnancy Test Strip

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More Product Details

Catalog Number

-

Brand Name

ChoiceMMed

Version/Model Number

HCG (3.0)

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

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Device Record Status

Public Device Record Key

0c2f111c-7623-4120-9591-0b235ccf51ff

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD." 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. 259