Who else makes this device?

Name: Status iFOBT Test Device and Sample Collection Tubes Refill Kit
Brand: Status iFOBT Test Device and Sample Collection Tubes Refill Kit

Hematology › Manual Hematology DevicesReagent, Occult Blood

Status iFOBT Test Device and Sample Collection Tubes Refill Kit

Status iFOBT Test Device and Sample Collection Tubes Refill Kit (50 Tests and 50 Tubes)

Registry build 21.09.26

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 Status iFOBT Test Device and Sample Collection Tubes Refill Kit
Listed by	Princeton BioMeditech Corp., United States
FDA product code	KHE
Device type	Reagent, Occult Blood
Device class	Class 2
Regulation	21 CFR 864.6550
Establishment	Manufacturer, Exporter
Record published	2017-10-31
Record revised	2022-06-10 (version 4)

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
Storage	Storage environment temperature 2 to 30 °C

Catalogue Numbers

Catalogue numbers for Status iFOBT Test Device and Sample Collection Tubes Refill Kit
Catalogue number	Size	Status
BSP-300-DT-00		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
K100817	2010-07-01

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.