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The minimum order quantity is 10 pieces.

Rapid Diagnostic Test Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR) with CE Certificate From China

Name: Rapid Diagnostic Test Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR) with CE Certificate From China
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 2000745785

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$0.30-3.80

1,000 Pieces

Sample price:US$3.00/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent, Monkeypox PCR Test

Ethylene Oxide Sterilization

Without Ethylene Oxide Sterilization

Model NO.

monkeypox

Quality Guarantee Period

One Year

Group

Adult

Logo Printing

Without Logo Printing

Material

Cassette/Panel/Cup

Certificates

ISO13485/CE/Cfda

Principle

Fluorescence PCR

Specimen

Blood/Pus

Form

Cup

Brand Name

Singclean/Other Brand

Storage

-25 Degrees Celsius

Transport Package

Cartons

Specification

25 tests/kit, 50 tests/kit

Trademark

Singclean/OEM

Origin

China

HS Code

3302100090

Production Capacity

5000/Day

Key features

Fluorescence PCR Principle: Utilizes advanced fluorescence PCR technology for rapid and accurate nucleic acid detection.

High Specificity: No cross-reaction with measles, rubella, parvovirus B19, varicella zoster, syphilis, or herpes simplex viruses.

Low Detection Limit: Minimum detection limit of 400 copies/mL ensures sensitivity for early diagnosis.

CE and ISO13485 Certified: Product holds CE certificate and manufacturer is ISO13485 certified for quality assurance.

OEM and ODM Services: Full customization available including brand name and packaging options.

High Precision: Coefficient of variation (CV%) for intra-assay precision is less than or equal to 5%.

Versatile Specimen Types: Suitable for testing serum, human pustular, or vesicular rash specimens.

Company profile

Importers and ExportersExhibition Experience

Hangzhou Singclean Medical Products Co., Ltd.

Zhejiang, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Full Customization CertifiedExport Year: Shanghai Port CertifiedNearest Port: Shanghai PortAverage Response Time: ≤4.91h

AI-Powered supplier vetting

SummaryThe supplier is identified as a manufacturing factory in Hangzhou’s Qiantang District, with a business scope covering medical devices, cosmetics, masks, disinfectants, technical services, and import/export activities. It reports ISO 9001:2015 and CE certifications, 100% finished-product inspection, 58 quality assurance and control inspectors, and documented corrective-action and complaint-handling procedures. Manufacturing contracts with associated subcontractors are in place, and the supplier offers OEM, ODM, and broad customization services. However, it reports no in-stock capacity, overseas warehouse, overseas showroom, overseas agents or branches, or SDK availability. No new product was developed in the past year, and the company did not conduct regular fire drills during that period. Customer-case evidence is limited to OEM service for well-known brands and participation in one offline trade event.

Supplier typeThe supplier is explicitly identified as a factory, with associated companies in manufacturing. Its registered business scope includes first-category medical device production, second-category medical device sales, cosmetics, masks, disinfectants, technical services, and import/export activities.

CertificationsThe supplier reports an ISO 9001:2015 management-system certificate and CE certification for products. It also states that quality assurance exists and that quality-control processes are supported by documented procedures and records.

R&D capabilityThe supplier reports no available SDK and no new products during the past year, which are explicit limitations for software-enabled and recent product innovation. It does provide ODM services, but the available evidence does not establish strong ongoing innovation capability.

Production capacityThe supplier is a manufacturing factory with 100% finished-product inspection, 58 quality assurance and control inspectors, listed mixing, filling, sterilizing, and packing equipment, and a reported peak-season fulfillment time of one month. Valid manufacturing contracts with associated subcontractors are in place, although the supplier has no in-stock capacity.

Customization capabilityThe supplier explicitly offers customization from samples, customization from designs, and full customization. It also provides ODM services and reports OEM capability for well-known brands, while its own-brand product quality-control capability covers Singclean and Singjoint.