What certifications does the product have?

The product is classified under IVDR and holds ISO13485 certification.

Covid 19

Name: Rapid Self AG Antigen Test Kit for Flu a/B/Covid 19
Brand: Glob Biotech (Nantong) Co, Ltd
SKU: 2203711035

Jiangsu, ChinaGlob Biotech (Nantong) Co, Ltd

US$1.00

1,000 Pieces

Product profile

Customization

Available

Classification

Biological Diagnostics

Type

Ivdr

Model NO.

FAB

Certification

ISO13485

Group

Ivdr

Transport Package

Cartons

Specification

2000pcs/carton

Trademark

Origin

China

HS Code

3822190090

Production Capacity

10000000000PCS/Year

Key features

Dual Influenza Detection: Qualitatively detects Influenza A and B viral nucleoprotein antigens in a single test.

Rapid Lateral Flow Technology: Utilizes lateral flow immunoassay for quick and accurate differential diagnosis.

ISO13485 Certified: Manufactured under ISO13485 certification ensuring high quality and safety standards.

IVDR Compliant: Classified as an IVDR product for professional in vitro diagnostic use.

OEM and ODM Services: Customization services available including OEM and ODM options for branding.

Professional Use Only: Intended strictly for professional and in vitro diagnostic applications.

Flexible Payment Terms: Accepts LC, T/T, D/P, PayPal, Western Union, and small-amount payments.

Fast Lead Time: Average lead time is one month for both peak and off-peak seasons.

Company profile

High Repeat Buyers ChoiceQuality AssuranceCustomization from DesignsManagement Certification

Glob Biotech (Nantong) Co, Ltd

Jiangsu, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedExport Year: 8 Years CertifiedNearest Port: Shanghai PortAverage Response Time: ≤2.16h CertifiedTerms of Payment: T/T, D/P, PayPal, etc.

AI-Powered supplier vetting

SummaryThe supplier is identified as a combined company based in Nantong, Jiangsu, China, with business activities covering medical devices, packaging materials, plastic products, molds, instruments, food, and import/export services. It reports written procedures and records for supplier-service assessment, corrective and preventive actions, and customer complaint handling. The supplier states that it provides OEM services to well-known brands, ODM services, and multiple levels of customization, including full customization and customization from samples or designs. It also reports new products within the past year. However, the available information does not establish specific certifications, production assets or capacity, named customer cases, or financial performance; it also states that no overseas warehouse, showroom, overseas branch or agent, or offline trade-show participation is available. The supplier reports lead times within 15 workdays in both peak and off-season periods and identifies Shanghai Port...

Supplier typeThe supplier is described as a combined company located in Nantong, Jiangsu, China. Its stated business scope includes medical devices, packaging materials, plastic products, molds, instruments, food, technology, and import/export activities, indicating a diversified trading and manufacturing-related profile rather than a narrowly defined supplier type.

After-Sales capabilityThe supplier states that it has clear procedures and followed records for handling customer complaints, as well as corrective and preventive actions. These records provide explicit evidence of a structured service-response process, although no service-level metrics or response times are given.

R&D capabilityThe supplier reports that it had new products during the past year and provides ODM services. It also reports no available SDK, which limits evidence of software-development support, but the new-product and ODM statements explicitly support product-development capability.

Customization capabilityThe supplier explicitly offers customization from samples, designs, full customization, minor customization, and flexible customization. Its company description also states that packaging, product formats, product shape, and other modifications can be customized, directly demonstrating broad customization coverage.

Product Q&A

Q:What is the intended use of this test kit?

It is for professional in vitro diagnostic use to detect influenza A and B antigens in nasopharyngeal or oropharyngeal swabs from individuals with respiratory symptoms.

Q:Does this test detect influenza C?

No, the test is not intended to detect influenza C antigens.

Q:What does a negative result mean?

Negative results are presumptive and should be confirmed by viral culture or molecular assay; they do not preclude infection.

Q:Can I customize the packaging or branding?

Yes, OEM and ODM services are available for custom branding and manufacturing.

Q:What are the payment terms?

We accept LC, T/T, D/P, PayPal, Western Union, and small-amount payments.