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)

LetsGetChecked Urine Sample Collection Kit (Uacr/Uacrl)

Name: LetsGetChecked Urine Sample Collection Kit (Uacr/Uacrl)
Brand: LetsGetChecked Urine Sample Collection Kit (Uacr/Uacrl)

A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically…

Registry build 21.09.26

A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

7manufacturers in China registered for this device type

1catalogue number

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 LetsGetChecked Urine Sample Collection Kit (Uacr/Uacrl)
Listed by	Privapath Diagnostics Ltd, Ireland
FDA product code	OIE
Device type	Urine Collection Kit (Excludes Hiv Testing)
Device class	Class 1
Regulation	21 CFR 864.3250
Establishment	Repacker / relabeller, Manufacturer
Record published	2025-07-07

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

Catalogue Numbers

Catalogue numbers for LetsGetChecked Urine Sample Collection Kit (Uacr/Uacrl)
Catalogue number	Size	Status
UO03S		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
Smilereader ovulation test kit	Equinox Biotech Co., Ltd.	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

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.