Antisera, All Types, Shigella Spp.

Who Makes This Device Type in China?

One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.

Suzhou Tianlong Biotechnology Co., Ltd. Jiangsu

How Is GNB Classified?

Antisera, All Types, Shigella Spp. is FDA product code GNB, Class 2, 21 CFR 866.3660.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2007. None was by a company in China. The root cause the FDA records most often is Nonconforming Material/Component (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Antisera, All Types, Shigella Spp.

Shigella Boydii Polyvalent 1 (1-6) Agglutinating Serum

Catalogue number R30163901, listed by Remel Europe Ltd, United Kingdom, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

BD Difco™ Shigella Antiserum Poly Group A1 S. Dysenteriae Serotypes 8–10

BD Difco™ Shigella Antiserum Poly Group A1, 3 mL

Antisera, All Types, Shigella Spp.

Shigella Boydii Pool Serum, 3 Ml

Catalogue number 66444, listed by SSI Diagnostica A/S, Denmark, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

BD Difco™ Shigella Antiserum Poly Group C S. Boydii Serotypes 1–7

Catalogue number 228361, listed by Becton, Dickinson AND Company, United States, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

Shigella Sonnei Pool Serum, 3 Ml

Catalogue number 66445, listed by SSI Diagnostica A/S, Denmark, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

Shigella Sonnei Fase I Serum, 3 Ml

Catalogue number 66446, listed by SSI Diagnostica A/S, Denmark, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

Shigella Antisera Set 2

Shigella Antisera Set 2 - A set containing 8 polyvalent and 11 monovalent antisera for serotyping Shigella, dysenteriae, Shigella flexneri, Shigella boydii and Shigella sonnei strains

Antisera, All Types, Shigella Spp.

BD Difco™ Alkalescens-Dispar Antiserum Poly Contains Types 1-4

BD Difco™ Alkalescens-Dispar Antiserum Poly Contains Types 1–4

Antisera, All Types, Shigella Spp.

Shigella Flexneri Pool Serum, 3 Ml

Catalogue number 66443, listed by SSI Diagnostica A/S, Denmark, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

Polyvalent Shigella Slide Antisera – Sonnei Phase 1 & 2

Catalogue number PL.6900, listed by pro-lab incorporated, Canada, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

Mast Assre

M10143 - Shigella boydii Type 9 Antiserum - 1 pack of 2ml

Antisera, All Types, Shigella Spp.

Shigella Dysentariae Pool Serum, 3 Ml

Catalogue number 66442, listed by SSI Diagnostica A/S, Denmark, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

EZ-Shigella One-Step Shigella Species Rapid Test

The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for…

Antisera, All Types, Shigella Spp.

BD Difco™ Shigella Antiserum Poly Group D S. Sonnei Serotypes I & II

Catalogue number 228371, listed by Becton, Dickinson AND Company, United States, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

Polyvalent Shigella Slide Antisera – Flexneri 1-6 X & Y

Catalogue number PL.6901, listed by pro-lab incorporated, Canada, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

Shigella Sonnei Fase II Serum, 3 Ml

Catalogue number 66447, listed by SSI Diagnostica A/S, Denmark, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

BD Difco™ Shigella Antiserum Poly Group C1 S. Boydii Serotypes 8–13

Catalogue number 227771, listed by Becton, Dickinson AND Company, United States, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

BD Difco™ Shigella Antiserum Poly Group a S. Dysenteriae Serotypes 1–7

Catalogue number 228341, listed by Becton, Dickinson AND Company, United States, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

BD Difco™ Shigella Antiserum Poly Group C2 S. Boydii Serotypes 14–18

Catalogue number 227781, listed by Becton, Dickinson AND Company, United States, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

Polyvalent Shigella Slide Antisera – Dysenteriae 1-10

Catalogue number PL.6902, listed by pro-lab incorporated, Canada, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

BD Difco™ Shigella Antiserum Poly Group B S. Flexneri Serotypes 1–6

Catalogue number 228351, listed by Becton, Dickinson AND Company, United States, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

Polyvalent Shigella Slide Antisera – Boydii 1-15

Catalogue number PL.6903, listed by pro-lab incorporated, Canada, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

Antisera, All Types, Shigella Spp.

6 catalogue numbers from R30164201, listed by Remel Europe Ltd, United Kingdom, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.

Antisera, All Types, Shigella Spp.

Mastr Assure

M10139 - Shigella boydii Type 5 Antiserum - 1 pack of 2ml

Antisera, All Types, Shigella Spp.

Antisera, All Types, Shigella Spp.

Shigella flexneri group (3)4 antiserum, 2ml

Antisera, All Types, Shigella Spp.

Mast Assure

M10106 - Shigella Antisera Set 3 - contains 8 polyvalent antisera for serotyping Shigella dysenteriae, Shigella flexneri, Shigella boydii and Shegella sonnei strains

Antisera, All Types, Shigella Spp.

Mast Assure Antisera

M10116 - Shigella dysenteriae Monovalent Typing Antiserum - Type 1 - 1 pack of 2ml

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer