Who else makes this device?

Name: First Response™ Pregnancy Early Result
Brand: First Response™ Pregnancy Early Result

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

First Response™ Pregnancy Early Result

First Response Early Result is an over the counter urine test that helps detect pregnancy by identifying human chorionic gonadotropin, or hCG. It is a qualitative test for use by the…

Registry build 21.09.26

First Response Early Result is an over the counter urine test that helps detect pregnancy by identifying human chorionic gonadotropin, or hCG. It is a qualitative test for use by the consumer. Reagents on a chromatographic strip react with the specimen inside a plastic test housing.

The absorbent pad receives urine directly from the stream or from a collected sample. The result is read in the housing window after the specified three minute interval. Pink line patterns indicate whether hCG has been detected, with the instructions defining the interpretation.

Listed Item

Pregnancy Kit

Early Testing

Testing before a missed period may produce a negative result despite pregnancy because urine hCG can still be below detection. Results require healthcare provider confirmation, particularly before decisions about medical care.

30manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

1recall

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 First Response™ Pregnancy Early Result
Listed by	Church & Dwight Co., Inc., United States
FDA product code	LCX
Device type	Kit, Test, Pregnancy, Hcg, Over The Counter
Device class	Class 2
Regulation	21 CFR 862.1155
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K123436
Record published	2023-01-31
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 First Response™ Pregnancy Early Result
Catalogue number	Size	Per pack	Status
00022600001317		4	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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K123567	2013-09-10
K123436	2013-08-26
K083716	2009-06-08
K070054	2007-05-04

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of First Response™ Pregnancy Early Result
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Family Dollar Stores, Llc.	510(k) number	2023-10-04	Class II	Storage	Products were stored outside of labeled temperature requirements.	329,044 total units
Family Dollar Stores, Llc.	510(k) number	2022-06-23	Class II	Storage	Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 – June 10, 2022.	77

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. 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
2023-01-25	Class II	No Marketing Application	Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no results reported on the APP screen) or to mi	780000 downloads

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.