PY0205

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

04049095160554

Basic UDI-DI

B-04049095160554

Reference / catalog number

PY0205

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. With the RIDA®GENE HLA-B27 kit HLA-B27 alleles in genomic DNA, isolated from human whole blood EDTA samples, are qualitatively detected by using real-time Polyermase Chain Reaction (PCR). The RIDA®GENE HLA-B27 kit is designed to assist in the diagnosis of patients with suspected spondylitis ankylosans (Bechterew’s disease) and other autoimmune diseases. The test is not to be used for tissue typing. The following HLA-B27 subtypes will be detected theoretically (in silico) with the sequence-specific primers: HLA-B*27:01 to 21, 23 to 152 and 154 to 164. Of these, the following subtypes were detected in vitro: HLA-B*27:01 to 05, 08 to 10, 12, 14, 23 and 26.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0106010401HLA-TYPING

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