Who else makes this device?

Name: Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum
Brand: Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum

Hematology › Blood Establishment ProductsSupplies, Blood-Bank

Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum

Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capture-P and Capture-P Ready-Screen Solid Phase assays.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (1), Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KSS
Manufacturer	City	Province	Registered as	Device types
Shenzhen Lilian Precision Mould Manufacturing Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	1
Ningbo Risenmed Technology Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	42
Jiangsu Goju Identification Technology Co., Ltd.	Yancheng	Jiangsu	Contract manufacturer	6

Record

Regulatory record for Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum
Listed by	Immucor, Inc., United States
FDA product code	KSS
Device type	Supplies, Blood-Bank
Device class	Class 1
Regulation	21 CFR 864.9050
Establishment	Specification developer, Repacker / relabeller, Manufacturer
510(k)	BK860017
Record published	2022-09-03

Specifications

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

Catalogue Numbers

Catalogue numbers for Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum
Catalogue number	Size	Status
0066905		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Rad-Sure™	Ashland Specialty Ingredients, G.P.	20
RadTag	Radtag Technologies, Inc.	12
Cascade	Musculoskeletal Transplant Foundation	5
MTS	Micro Typing Systems, Inc.	5
Capture Liss	Immucor, Inc.	5
GPS® III Platelet Concentration System	Biomet Biologics, LLC	4
MacoPress Smarter	Delcon SRL	4
Marketlab Inc	Marketlab Incorporated	4
Capture-P	Immucor, Inc.	3
GPS® III	Biomet Biologics, LLC	2
Typesafe 2.0	Typenex Medical, LLC	2
Capture-P Indicator Red Cells	Immucor, Inc.	2

Showing 12 of 48. All products under Supplies, Blood-Bank

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.