Organization name

Shanghai BioGerm Medical Technology Co., Ltd.

SRN

CN-MF-000018164

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Caution

  [Warnings and Precautions] Read the instruction carefully before use. For professional in vitro diagnostic use only. Use separate areas and dedicated instruments to avoid contamination. Bring reagents to room temperature, mix well, and centrifuge briefly. Avoid bubbles; ensure caps are tightly closed. Disinfect the work area with 10% sodium hypochlorite, 75% ethanol, and UV after use. Handle all specimens as potentially infectious and follow biosafety procedures. Improper storage, transport, or sampling may affect results; interpret with clinical data. Dispose of materials per local or WHO regulations. Report any serious incident to the manufacturer and competent authority.

Primary placement in Germany; available across 1 country total.

Trade name

Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

06974677692544

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

6974677692537K9

Reference / catalog number

IS-FZ-064-50-CE

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

This kit is intended for in vitro qualitative detection of DNA from monkeypox virus (clade I/II) in lesion exudate swab samples of suspected monkeypox cases. Results are for the identification of monkeypox virus (clade I/II) DNA, however, the assay does not distinguish between clade I and clade II. Positive results are indicative of the presence of monkeypox virus (clade I/II) DNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results obtained with this device do not preclude MPXV (clade I/II) infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. For in vitro diagnostic use only. For professional lab use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105040599VIROLOGY - NA REAGENTS - OTHER

• IVDR Class C medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.