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)

UroMap Specimen Collection Kit

Name: UroMap Specimen Collection Kit
Brand: UroMap Specimen Collection Kit

The UroMap Specimen Collection Kit is intended for the collection and processing of urine specimens for the assessment of the probability of T-cell mediated rejection and BK virus…

Registry build 21.09.26

The UroMap Specimen Collection Kit is intended for the collection and processing of urine specimens for the assessment of the probability of T-cell mediated rejection and BK virus nephropathy in kidney transplant patients. The UroMap Specimen collection kit is not intended for home use and is intended to be used by trained medical personnel.

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 UroMap Specimen Collection Kit
Listed by	CareDx, Inc., United States
FDA product code	OIE
Device type	Urine Collection Kit (Excludes Hiv Testing)
Device class	Class 1
Regulation	21 CFR 864.3250
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2023-02-10

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, serial number
Storage	Storage environment temperature 15 to 25 °C

Catalogue Numbers

Catalogue numbers for UroMap Specimen Collection Kit
Catalogue number	Size	Status
UM-00001		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.