As a potential mother, you need to know everything about your pregnancy test. Whether you’ve chosen the New Choice Pregnancy Test or still haven’t decided, CPG Health answers your question, “Who makes the New Choice Pregnancy Test cassette?”
Disambiguation. The New Choice One Step Pregnancy Test is a cassette-based pregnancy test. The New Choice Plus One Step Pregnancy Test is an in-stream pregnancy test. Right now, we’re answering your questions about the New Choice One Step Pregnancy Test, which is a cassette-based product.
Who makes the New Choice Pregnancy Test cassette?
According to FDA records, Guangzhou Wondfo Biotech Co., Ltd. makes the New Choice Pregnancy Test cassette.
Guangzhou has registered this product under the device name, “SCI International Inc. New Choice Pregnancy Test (cassette).”
The company manufactures the New Choice Pregnancy Test in China and exports it to one of several American distributors.
According to the product’s package, the New Choice cassette is made in China and packaged in the USA.
New Choice FDA records
SCI International, document K012215
We found New Choice at Home Pregnancy (HCG) Test Cassette registered under SCI Internationa/Saless Enterprise:
The SCI International document number, K012215 references document K123703 (See below).
- K123703 Statement.
- K123703 Decision summary.
FDA Document K012215 has an effective date of 7/29/2013.
At this time, the product was manufactured by Acon Laboratories, Inc.
Saless Enterprises, document K123703
We found Saless Enterprise Inc., New Choice Pregnancy Test(Cassette) records at the U.S. Click the image to view the FDA document.
FDA document K123703 has an effective date of 12/4/2018.
At this time, the product was manufactured by Healgen Scientific, LLC. It’s registered undewr the device name, “HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE).”
SCI International Inc. New Choice Pregnancy Test (cassette), document K043443
FDA document K043443 has an effective date of 12/27/2019. This document is the most-recent data stored by the FDA.
Most recently, the FDA records Guanzhou Wondfo Biotec Co., Ltd. as the manufacturer of the New Choice One Step Pregnancy test cassette.
Check out the latest documents:
Distributor
A manufacturer makes a product. Distributors package and distribute the product to stores.
According to the product’s package, a company named Saless Enterprises Inc. distributes the New Choice Pregnancy Test cassette.
Saless Enterprises Inc.
If you look at the inside of your New Choice Pregnancy Test cassette, you’ll see that it lists the following company as its distributor:
Saless Enterprises Inc.
5904 Enterprise Court
Frederick, MD. 21703
You can visit Saless Enterprises on the web: https://scimedic.com/. On the company’s “Distributors” page, you can clearly see the New Choice Pregnancy Test on display. You cannot, however, buy this product from the Saless website.
Saless Enterprises is a private label supplier and distributor. It may repackage the New Choice One Step Pregnancy Test for sale under store brands and other reseller.
New Choice Pregnancy Test product specifications
According to the Saless Enterprises product catalog, the New Choice Pregnancy Test features:
- NBE to E.P.T.
- Private label in carton.
- Includes dropper.
- 25 mIU/ml sensitivity.
- 99% accurate.
- Results in two to three minutes.
Now, let’s get down to the answer to your question.
Manufacturer
As already noted, CPG Health has used FDA data to identify Guangzhou Wondfo Biotech as the current manufaturer of the New Choice Pregnancy Test in China.
How do I contact the Guangzhou?
If you have questions about your New Choice product, you may write to the manufacturer’s USA address:
Guangzhou Wondfo Biotech Co., Ltd.
8903 SPRUCE MILL DRIVE
Yardley, PA 19087
You can also read the FDA’s complete data file on this test right here.
What does this mean?
The New Choice Pregnancy Test (cassette) has been made by several manufacturers. Based on the most recent information available, Guangzhou Wondfo Biotech currently makes the product.
Learn more about New Choice
Check out the below additional resources about the New Choice One Step Pregnancy Test and the New Choice Plus One Step Pregnancy Tests.
