Is this test CE approved?

Yes, the Singclean C-19 Antigen Test Kit is CE approved, ensuring it meets necessary regulatory standards.

Can this test detect bacterial infections?

No, a positive result does not rule out bacterial infection or co-infection with other viruses. It specifically detects C-19 antigen.

Singclean Rapid Multi-Specification Saliva Antigen Test CE Approved

Name: Singclean Rapid Multi-Specification Saliva Antigen Test CE Approved
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 2041891975

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$1.50-3.00

1,000 Pieces

Sample price:US$5.00/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Use

Detection of Igg and Igm Antibodies to 2019 Novel

Speciems

Human Saliva

Feature 1

Fast Results in 2-15 Minutes

Feature 2

One Step Disinfection Tablets and Lancets

Feature 3

High Sensitivity and Specificity

Transport Package

Carton or Customized Package

Specification

1 test/box; 20 test/box; 50 test/box

Trademark

Singclean

Origin

China

HS Code

3002100090

Production Capacity

50000/Day

Key features

Non-Invasive Saliva Sampling: Uses saliva swab instead of nasopharyngeal swab, reducing risk to healthcare workers and improving patient comfort.

Rapid Results in 15 Minutes: Provides qualitative detection results in just 15 minutes, helping address global shortages of swabs and PPE.

High Accuracy Comparable to PCR: Offers a high level of accuracy comparable to nasopharyngeal swab testing based on clinical data of 397 samples.

No Instrument Required: Affordable one-step test that does not require specialized laboratory instruments, suitable for point-of-care use.

CE Approved Certification: Product holds CE approval, ensuring compliance with European health, safety, and environmental protection standards.

ODM Service Available: Manufacturer offers ODM services with 24 R&D engineers, allowing for customized product solutions.

Comprehensive Safety Features: Includes one-step disinfection tablets and lancets, ensuring safe and hygienic self-sampling procedures.

Company profile

Hangzhou Singclean Medical Products Co., Ltd.

Zhejiang, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service AvailableExport Year: 2022-12-20 CertifiedNearest Port: Ningbo Port, Shanghai PortAverage Response Time: ≤3.10h CertifiedTerms of Payment: LC, T/T, D/P, etc.

AI-Powered supplier vetting

SummaryThe supplier is a China-based medical-products factory headquartered in Hangzhou, Zhejiang, with 420 employees and operations established in the early 2000s. It reports seven production lines, a 17,000 m² manufacturing plant, ISO 9001:2015 and ISO 14001:2015 certification, OEM/ODM services, and stated antigen rapid test-kit capacity of 10 million pieces annually. Its products and services cover in-vitro diagnostics, absorbable hemostatic products, hyaluronic-acid-related medical products, and other medical devices. The supplier reports export coverage across multiple global regions, more than 120 export destinations in a company description, and delivery within 15 working days off-peak or one month during peak periods. Evidence supports strengths in factory operations, quality systems, production scale, customization, and R&D. After-sales capability, financial credibility, and specific customer cases are not sufficiently documented in the provided slices.

Supplier typeThe supplier is identified as a manufacturing factory in Hangzhou, China, with a limited-company structure and medical-device products as its main offering. This supports classification as a direct medical-products manufacturer rather than only a trading intermediary.

CertificationsThe supplier reports ISO 9001:2015 and ISO 14001:2015 certifications, along with other unspecified certifications. These explicitly indicate documented quality-management and environmental-management systems, although the unspecified certifications cannot be assessed further.

R&D capabilityThe supplier reports dedicated R&D engineers, more than 20 years of absorbable-biomaterials expertise, a strong R&D team, and ongoing development of medical and tissue-engineering products. The slices explicitly support substantial innovation activity and industry experience.

Production capacityThe supplier reports a 17,000 m² plant, seven production lines, daily capacity of 500,000 pieces in a company description, annual antigen rapid test-kit output of 10 million pieces, and stated delivery times of within 15 working days off-peak and one month during peak season. These figures provide explicit evidence of meaningful production scale and fulfillment capability.

Customization capabilityThe supplier explicitly offers OEM and ODM services according to client needs. This is direct evidence that it can support customized product development or manufacturing arrangements.

Product Q&A

Q:What sample type is used for this test?

The test uses human saliva swabs as the sample type, which is non-invasive and more comfortable than nasal swabs.

Q:How long does it take to get results?

Results are available in 15 minutes, providing a rapid qualitative detection of the C-19 antigen.

Q:Is this test accurate compared to PCR?

Yes, the test offers a high level of accuracy that is comparable to nasopharyngeal swab testing, based on clinical data.

Q:Do I need special equipment to use this kit?

No, this is an affordable one-step test that does not require any specialized instruments or laboratory equipment.

Q:What does a positive result indicate?

A positive result indicates the presence of C-19 antigen in the specimen. However, reactive specimens should be confirmed with alternative testing methods.