Who else makes this device?

Name: One Step Pregnancy Test
Brand: One Step Pregnancy Test

Clinical Chemistry › Test SystemsKit, Test, Pregnancy, Hcg, Over The Counter

One Step Pregnancy Test

Catalogue number 10001, listed by Universal Corporation Limited, India, under Kit, Test, Pregnancy, Hcg, Over The Counter. 30 manufacturers in China are registered for this product code.

Registry build 21.09.26

30manufacturers in China registered for this device type

1catalogue number

5recalls on this code

Who Else Makes It

Concentrated in Zhejiang (9), Guangdong (5), Shanghai (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LCX
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Hangzhou AllTest Biotech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	48
Hangzhou Biotest Biotech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	41
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Core Technology Co., Ltd.	Changping District	Beijing	Contract manufacturer	14
Abbott Diagnostics (Shanghai) Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	4
Planet(Shanghai) International Co., Ltd.	Shanghai	Shanghai	Exporter	93
Hynaut Health Technology Co., Ltd.	Qingdao	Shandong	Contract manufacturer	68
AID United International Co., Limited	Shanghai	Shanghai	Specification developer	65
Assure Tech. (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	48
Guangzhou Wondfo Biotech Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	44
W.h.p.m. Bioresearch & Technology Co., Ltd.	Beijing	Beijing	Manufacturer	37

Showing 12 of 30. All 30 manufacturers in China registered for Kit, Test, Pregnancy, Hcg, Over The Counter

Record

Regulatory record for One Step Pregnancy Test
Listed by	Universal Corporation Limited, India
FDA product code	LCX
Device type	Kit, Test, Pregnancy, Hcg, Over The Counter
Device class	Class 2
Regulation	21 CFR 862.1155
Establishment	Repacker / relabeller
Record published	2021-10-15
Record revised	2023-07-06 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for One Step Pregnancy Test
Catalogue number	Size	Status
10001		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
CVS Health	Woonsocket Prescription Center, Incorporated	55
Walgreens	Walgreen Co.	37
H.E.B	H. E. Butt Grocery Company	26
Clearblue	SPD Swiss Precision Diagnostics Gmbh	23
Amplim	Amplim, LLC	20
Up & Up	Target Health, Inc.	17
Wondfo	Wondfo USA Co., Ltd.	16
Equate	Wal Mart Stores, Inc	14
Meijer	Meijer, Inc.	12
Leader	Cardinal Health 110, Inc.	10
Rite Aid Pharmacy	SPD Swiss Precision Diagnostics Gmbh	8
VeriQuick	Fourstar Group	8

Showing 12 of 327. All products under Kit, Test, Pregnancy, Hcg, Over The Counter

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of One Step Pregnancy Test
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Universal Corporation Limited	UDI-DI	2023-05-22	Class II	Other	Universal Meditech Inc. was violatively distributing PrestiBio” Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast” Ketone Test Strips and PrestiBio” Ketone Test Strips without marketing autho	147,000 tests

Recalls

4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2023-05-22	Class II	Other	Universal Meditech Inc. was violatively distributing PrestiBio” Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast” Ketone Test Strips and PrestiBio” Ketone Test Strips without marketing autho	Unknown
2023-05-22	Class II	Other	Universal Meditech Inc. was violatively distributing PrestiBio” Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast” Ketone Test Strips and PrestiBio” Ketone Test Strips without marketing autho	3,304 tests
2023-05-22	Class II	Other	Universal Meditech Inc. was violatively distributing PrestiBio” Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast” Ketone Test Strips and PrestiBio” Ketone Test Strips without marketing autho	Unknown
2023-05-22	Class II	Other	Universal Meditech Inc. was violatively distributing PrestiBio” Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast” Ketone Test Strips and PrestiBio” Ketone Test Strips without marketing autho	45,420 tests

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.