C0601

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

04049095030000

Basic UDI-DI

4049095C060100000JB

Reference / catalog number

C0601

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 RIDASCREEN® Clostridium perfringens Enterotoxin is a manual enzyme immunoassay for the direct qualitative detection of Clostridium perfringens enterotoxin in untreated human stool samples from people with symptoms of gastroenteritis. The RIDASCREEN® Clostridium perfringens Enterotoxin is a diagnostic aid for the detection of a bacterial infection with enterotoxin-producing Clostridium perfringens bacteria in conjunction with other clinical and laboratory findings. Negative results do not rule out infection with enterotoxin-producing Clostridium perfringens bacteria 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.

• W0105011799BACTERIOLOGY IMMUNOASSAY - OTHER

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• Expiration date
• Manufacturing date
• Serial number
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