Device, Specimen Collection

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Zhejiang and Shanghai: 3 hold an FDA registration.

Hangzhou Best Valley Medical Technology Co., Ltd. Zhejiang
Sterigenics Shanghai E Beam Ltd. Shanghai, contract manufacturer
Zhejiang Gongdong Medical Technology Co., Ltd. Zhejiang, contract manufacturer

How Is LIO Classified?

Device, Specimen Collection is FDA product code LIO, Class 1, 21 CFR 866.2900.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are No Marketing Application (1), Incorrect or no expiration date (1) and Nonconforming Material/Component (1).

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

Device, Specimen Collection

OEM Customer Specific

Pediatric Insert Cups, 13 mm, Beckman Coulter, Inc. Part Number 81916

Device, Specimen Collection

BD BBL Polyester Fiber-Tipped Applicator Swab

Catalogue number 220690, listed by Becton, Dickinson AND Company, United States, under Device, Specimen Collection. 3 manufacturers in China are registered for this product code.

Device, Specimen Collection

Amies Charcoal Gel,Single Swab PK/50

Catalogue number R723045, listed by Remel, Inc., United States, under Device, Specimen Collection. 3 manufacturers in China are registered for this product code.

Device, Specimen Collection

Amies Clear Gel,Single Swab PK/500

Catalogue number R723000, listed by Remel, Inc., United States, under Device, Specimen Collection. 3 manufacturers in China are registered for this product code.

Device, Specimen Collection

BD Affirm™ Vpiii Sample Collection Sets

Kit Affirm Sample Collection

Device, Specimen Collection

Amies Clear Gel,Dual Swab PK/50

Catalogue number R723015, listed by Remel, Inc., United States, under Device, Specimen Collection. 3 manufacturers in China are registered for this product code.

Device, Specimen Collection

Amies Clear Gel,Wire Shaft Swab PK/100

Catalogue number R723020, listed by Remel, Inc., United States, under Device, Specimen Collection. 3 manufacturers in China are registered for this product code.

Device, Specimen Collection

Rapid fFN

FFN Specimen Collection KIT, 25PK

Device, Specimen Collection

RealTime

Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glycosylase (UNG)

Device, Specimen Collection

Amies Clear Gel,Single Swab PK/50

Catalogue number R723005, listed by Remel, Inc., United States, under Device, Specimen Collection. 3 manufacturers in China are registered for this product code.

Device, Specimen Collection

simpli-COLLECT

simpli-COLLECT HPV Collection Kit

Device, Specimen Collection

Binx Io

Female collection kit

Device, Specimen Collection

OMNIgene Oral

Nucleic Acids Specimen Collection and Stabilization, Saliva.

Device, Specimen Collection

Amies Clear Gel,Dual Swab PK/500

Catalogue number R723010, listed by Remel, Inc., United States, under Device, Specimen Collection. 3 manufacturers in China are registered for this product code.

Device, Specimen Collection

CVS Health at Home

Dry blood spot card collection kit utilizing 903 Five Spot Blood Card and Hologic Aptima Urine transport tube.

Device, Specimen Collection

Amies Clear Gel,Wire Shaft PK/50

Catalogue number R723025, listed by Remel, Inc., United States, under Device, Specimen Collection. 3 manufacturers in China are registered for this product code.

Device, Specimen Collection

Isolator™ 1.5 Ml Microbial Tubes

The ISOLATOR 1.5 mL microbial tube is intended for use in the collection of small volume pediatric blood samples to be used in the isolation of microorganisms.

Device, Specimen Collection

Puritan

Puritan Lim Broth Transport Medium, 2ml

Device, Specimen Collection

BD Affirm™ Vpiii Ambient Temperature Transport System

Kit Affirm Att System 100 Ea

Device, Specimen Collection

BD Affirm™ Vpiii Sample Collection Swabs

Catalogue number 446251, listed by Becton, Dickinson AND Company, United States, under Device, Specimen Collection. 3 manufacturers in China are registered for this product code.

Device, Specimen Collection

Puritan Opti-Swab

Puritan Opti-Swab Media Transport System - Sterile Elongated Flock Swab 1ml Amies Medium

Device, Specimen Collection

Cardinal Health

Collection and Transport Swab Microorganism Collection and Transport System

Device, Specimen Collection

Thermo Scientific Protocol™ Parasitology System

2 catalogue numbers from 23-005-50, listed by Fisher Diagnostics, United States, under Device, Specimen Collection. 3 manufacturers in China are registered for this product code.

Device, Specimen Collection

Xpert Vaginal/Endocervical Specimen Collection Kit

Xpert Vaginal/Endocervical Specimen Collection Kit; 50 pack

Device, Specimen Collection

Covidien

Isolator 1.5 mL Tubes, 51C5 Product, 10 x 50 mm, Abbott Diagnostics

Device, Specimen Collection

EndosacTM

Specimen Collection Container

Device, Specimen Collection

Xpert Urine Specimen Collection Kit

Xpert Urine Specimen Collection Kit; 50 pack

Device, Specimen Collection

Starswab II Bacteriology Culture Collection and Transport System

Starswab II Bacteriology Culture Collection and Transport System with Liquid Amies and double standard plastic shaft rayon tip swab applicator.

Device, Specimen Collection

Puritan UniTranz-RT

Puritan UniTranz-RT 3ml Filled Vial w/ Sterile Mini-tip & Standard Polyester Swabs

Device, Specimen Collection

Sigma Virocult

Sigma Virocult, 1 x Mini Foam 78mm BP & 1 x Std Foam 79mm BP

Device, Specimen Collection

Caplugs/Evergreen

Sputocol Sputum Collect Frstnd

Device, Specimen Collection

Transwab

Transwab, Standard Plastic, Theatre Packed, Amies with Charcoal

Device, Specimen Collection

Sigma Transwab

Sigma Transwab (fecal), Screw Vial, Green cap 2ml Cary Blair, Plastic Foam

Device, Specimen Collection

Bacti-Swab

BactiSwab NPG (Mod Stuarts) PK/100

Device, Specimen Collection

Remel

Cary-Blair w/Ind/SAF/Empty Vial PK/84SET

Device, Specimen Collection

Vacuette

Urine CCM Set VACUETTE® Urine CCM Tube + Urine Transfer Device (454486+450751), single-packed, Round Base, 4 ml, 13x75

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