Who else makes this device?

Name: Acceava®
Brand: Acceava®

Acceava® · Antigens, All Groups, Streptococcus Spp. → Immunology & Microbiology

6manufacturers in China registered for this device type

1catalogue number

3recalls on this code

Who Else Makes It

Concentrated in Zhejiang (3), Guangdong (1), Jiangsu (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 GTY
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Abon Biopharm (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	17
Hangzhou AllTest Biotech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	48
Guangzhou Wondfo Biotech Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	44
Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.	Nantong	Jiangsu	Manufacturer	11
BD Rapid Diagnostics (Suzhou) Co., Ltd.	China (Jiangsu) Pilot Free Trade Zone Suzhou Area		Manufacturer	6

Record

Regulatory record for Acceava®
Listed by	Alere San Diego, Inc., United States
FDA product code	GTY
Device type	Antigens, All Groups, Streptococcus Spp.
Device class	Class 1
Regulation	21 CFR 866.3740
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published	2016-09-24
Record revised	2026-03-13 (version 5)

Specifications

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

Catalogue Numbers

Catalogue numbers for Acceava®
Catalogue number	Size	Per pack	Status
92001		50	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
McKesson	Mckesson Medical-Surgical Inc.	5
Sofia	Quidel Corp.	4
QuickVue	Quidel Corp.	4
Cardinal Health	Cardinal Health 200, LLC	3
Strepaim	Germaine Laboratories, Inc.	3
Rapid Response	Btnx Inc.	3
Status Strep A Flip	Princeton BioMeditech Corp.	3
Henry Schein	Henry Schein, Inc.	3
Icon	Beckman Coulter, Inc.	2
Poly stat	Polymedco, Inc.	2
Group B Streptococcus Detection Kit(Immunochromatography)	Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.	2
Status Strep A Plus	Princeton BioMeditech Corp.	2

Showing 12 of 148. All products under Antigens, All Groups, Streptococcus Spp.

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Acceava®
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Cypress Medical Products, Ltd.	UDI-DI	2024-08-20	Class II	Process control	Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.	5 kits

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2011-09-01	Not classified	Process change control	Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist devices from the single lot that was recalled in January 12, 2011 to all lots of product that were on the market within the expiry p	1,859,430 devices (228 lots)	2012-06-28
2011-09-01	Not classified	Process change control	Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist devices from the single lot that was recalled in January 12, 2011 to all lots of product that were on the market within the expiry p	2,797,600 devices (228 lots)	2012-06-28
2011-01-12	Not classified	Pending	The recall was initiated after the Investigation of customer-reported complaints, testing of market retention and returned product, It was determined that this lot of product has demonstrated an elevated Incidence of non-specific binding, p	814 kits/24,420 devices	2012-06-26

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.

Acceava®