PM2305

Organization name

R-Biopharm AG

SRN

DE-MF-000007993

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04049095161742

Basic UDI-DI

4049095PM23050000JU

Reference / catalog number

PM2305

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

For in vitro diagnostic use. The RIDA®Prime H. pylori BDM test, which can be performed manually or automatically, is a multiplex real-time PCR for the direct qualitative detection of Helicobacter pylori DNA and the DNA of clarithromycin resistance (mutations A2142G, A2142C, and A2143G) in untreated human biopsy samples from people with signs and symptoms of acute gastroenteritis. The RIDA®Prime H. pylori BDM test is intended to support the diagnosis of Helicobacter pylori infection and any clarithrornvcin resistance (mutations A2142G, A2142C, and A2143G) in patients with symptoms of gastric disease in conjunction with other clinical and laboratory findings. Negative results do not rule out infection with Helicobacter pylori or the presence of clarithromycin resistance and should not be used as the sole basis for diagnosis. The product is intended for professional use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0105010403H. PYLORI DETECTION BY NA REAGENTS

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• Expiration date
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