Who else makes this device?

Name: Streptococcus reference strain group B type IX
Brand: Streptococcus reference strain group B type IX

Immunology & Microbiology › Serological ReagentsAntigens, All Groups, Streptococcus Spp.

Streptococcus Reference Strain Group B Type IX

Catalogue number 84910, listed by SSI Diagnostica A/S, Denmark, under Antigens, All Groups, Streptococcus Spp. 6 manufacturers in China are registered for this product code.

Registry build 21.09.26

6manufacturers in China registered for this device type

1catalogue number

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 Streptococcus reference strain group B type IX
Listed by	SSI Diagnostica A/S, Denmark
FDA product code	GTY
Device type	Antigens, All Groups, Streptococcus Spp.
Device class	Class 1
Regulation	21 CFR 866.3740
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2021-08-01

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 8 to 25 °C

Catalogue Numbers

Catalogue numbers for Streptococcus reference strain group B type IX
Catalogue number	Size	Status
84910		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.

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.