RE52071

Organization name

IBL International GmbH

SRN

DE-MF-000015709

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW266

  EUDAMED did not publish a description for this code.
• CW267

  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

04049325029781

Basic UDI-DI

4049325IVR06080001BTF

Reference / catalog number

RE52071

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

Enzyme immunoassay for the in-vitro-diagnostic quantitative determination of 17-OH-Progesterone in human serum and EDTA plasma from women, men, and children. This test is intended as an aid to diagnosis and monitoring of congenital adrenal hyperplasia, in which 17-OH-Progesterone levels are found to be elevated in comparison with a corresponding population of apparently healthy individuals due to genetic 21-hydroxylase deficiency. Additionally, other clinical observations such as physical exams, quantification of other steroidal hormones (androstenedione and cortisol) and genetic testing are employed to assess the status of congenital adrenal hyperplasia. This test is intended as an aid to diagnosis and monitoring of late-onset congenital adrenal hyperplasia, in which 17-OH-Progesterone levels are found to be elevated in comparison with a corresponding population of apparently healthy individuals due to perturbations (21-hydroxylase deficiency, or androgen “backdoor” pathway) in the metabolism of 17-OH-Progesterone that leads to the accumulation of this steroid. Additionally, other clinical observations such as physical exams, quantification of other steroidal hormones (androstenedione, cortisol, and dihydrotestosterone), and genetic testing are employed to assess the status of late-onset congenital adrenal hyperplasia. In certain cases of congenital adrenal hyperplasia, 17-OH-Progesterone levels are quantified before and after stimulation with ACTH. The 17-OH-Progesterone ELISA is NOT appropriate for use in neonatal screening and for monitoring patients with hypogonadotropic hypogonadism. The test kit is intended for professional laboratory use by trained personnel. The test kit is not for home or layperson use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W010205010717 OH PROGESTERONE

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• Expiration date
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