PY4215

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

04049095161100

Basic UDI-DI

B-04049095161100

Reference / catalog number

PY4215

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

For in-vitro diagnostic use. The RIDA®GENE Lac Intol test, which is performed on the LightCycler® 480 II, is a multiplex real-time PCR for the qualitative detection and differentiation of C13910 & G22018 as well as their SNPs (single nucleotide polymorphisms) C13910T & G22018A in the human MCM6 gene from human whole blood EDTA samples from persons with signs and symptoms of lactose intolerance. The RIDA®GENE Lac Intol test is intended to aid in the diagnosis of patients with symptoms of lactose intolerance in connection with other clinical and laboratory findings. The test result 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.

• W0106010199MONOGENETIC DISORDERS TESTS - OTHER

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