Who else makes this device?

Name: OcculTech Fecal Occult Blood Rapid Test
Brand: OcculTech Fecal Occult Blood Rapid Test

Hematology › Manual Hematology DevicesReagent, Occult Blood

OcculTech Fecal Occult Blood Rapid Test

The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an immunochomatography based in-vitro test designed for qualitative detection of fecal occult blood that can be…

Registry build 21.09.26

The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an immunochomatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices.

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Zhejiang (2), Guangdong (1), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KHE
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	5
Guangzhou Wondfo Biotech Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	44
W.h.p.m. Bioresearch & Technology Co., Ltd.	Beijing	Beijing	Manufacturer	37
Chong Qing Teco Huayi Pharm. Co.	Shapingba Dist.	Chongqing	Contract manufacturer	18

Record

Regulatory record for OcculTech Fecal Occult Blood Rapid Test
Listed by	YD Diagnostics, South Korea
FDA product code	KHE
Device type	Reagent, Occult Blood
Device class	Class 2
Regulation	21 CFR 864.6550
Establishment	Manufacturer
Record published	2019-08-13
Record revised	2022-11-28 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for OcculTech Fecal Occult Blood Rapid Test
Catalogue number	Size	Status
IM706-100M		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
OC-Light S	Polymedco Cancer Diagnostic Products LLC	59
McKesson	Mckesson Medical-Surgical Inc.	21
Hemosure	Hemosure Inc.	21
Hemoccult	Beckman Coulter, Inc.	17
Henry Schein	Henry Schein, Inc.	14
PremierPro	Prestige Ameritech	11
hema-screen Specific	Immunostics, Inc.	9
InSure® ONE™	Enterix Inc.	8
InSure FIT	Enterix Inc.	7
hema-screen	Immunostics, Inc.	7
ADS Medical	W.h.p.m., Inc.	7
QuickVue	Quidel Corp.	6

Showing 12 of 135. All products under Reagent, Occult Blood

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K060953	2006-09-18

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.