What is FDA product code OIE?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Hematology › Pathology InstrumentationUrine Collection Kit (Excludes Hiv Testing)

Smilereader Ovulation Test Kit

Name: Smilereader ovulation test kit
Brand: Smilereader ovulation test kit

3 catalogue numbers from 81019, listed by Equinox Biotech Co., Ltd., China, under Urine Collection Kit (Excludes Hiv Testing). 7 manufacturers in China are registered for this product code.

Registry build 21.09.26

7manufacturers in China registered for this device type

3catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (3), Jiangsu (2), Guangdong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OIE
Manufacturer	City	Province	Registered as	Device types
Conod Medical Co., Limited	Changshu	Jiangsu	Contract manufacturer	48
Zhejiang Gongdong Medical Technology Co., Ltd.	Taizhou	Zhejiang	Contract manufacturer	40
Primecare Medical (Suzhou) Co., Ltd.	Changshu	Jiangsu	Contract manufacturer	20
Principle & Will Biotech (Pinghu) Co., Ltd.	Pinghu	Zhejiang	Contract manufacturer	39
Hangzhou Primecare Medical Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Phase Scientific (Shenzhen) Company Limited	Shenzhen	Guangdong	Repacker / relabeller	8
Equinox Biotech Co., Ltd.	Shantou	Guangdong	Manufacturer	5

Record

Regulatory record for Smilereader ovulation test kit
Listed by	Equinox Biotech Co., Ltd., China
FDA product code	OIE
Device type	Urine Collection Kit (Excludes Hiv Testing)
Device class	Class 1
Regulation	21 CFR 864.3250
Establishment	Manufacturer, Exporter
Premarket notification	Exempt
Record published	2017-08-15
Record revised	2025-06-19 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 35.6 to 86 °F

Catalogue Numbers

Catalogue numbers for Smilereader ovulation test kit
Catalogue number	Size	Status
81019		In distribution
81002		In distribution
82351		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medical Action Industries	Medical Action Industries, Inc.	15
Medline	Medline Industries, Inc.	4
Vacuette	Greiner BIO-ONE Gmbh	4
Recopad	Medfire Innovations Inc.	3
David	Equinox Biotech Co., Ltd.	3
Everlywell Urine Collection Kit	Everly Health, Inc.	2
Urine Raku-Ryu Cup	Takahashi Keisei Corporation	2
Therapak	Therapak, LLC	2
BD Vacutainer Urine Complete Cup Kit	Becton, Dickinson AND Company	2
SureStep Vacutainer Urine Sampling Kit	C.R. Bard, Inc.	2
LotFancy	Equinox Biotech Co., Ltd.	1
DrKea+	Equinox Biotech Co., Ltd.	1

Showing 12 of 32. All products under Urine Collection Kit (Excludes Hiv Testing)

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.