Biotinidase - newborn screening
ANVISA technical name: BIOTINIDASE - TRIAGEM NEONATAL
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4registrations
4currently valid
2registration holders
2manufacturers
2countries
IIIrisk class
Related device types
- Amino acids - newborn screening 13
- Systems, discs and strips for specific anti-IgE (allergens), single or grouped - food screening panels 13
- Systems, discs and strips for specific anti-IgE (allergens), single or grouped - respiratory/inhalant screening panels 7
- Combined parameters in one product (III) - newborn screening 7
- 17-Hydroxyprogesterone (17-OHP) - newborn screening 5
- Thyroid-stimulating hormone (TSH) - newborn screening 5
- Galactose - newborn screening 5
- Anti-TSH receptor antibody (TRAb) - newborn screening 5
- Glucose-6-phosphate dehydrogenase (G6PD) - newborn screening 4
- Hemoglobin variants - newborn screening 4
- Free estriol - congenital disorder screening 4
- Immunoreactive trypsin (IRT) - newborn screening 3
- Thyroxine (T4) - newborn screening 2
- Combined parameters in one product (IV) - newborn screening 2
All registrations
| Product | Class | Holder | Published | Status |
|---|---|---|---|---|
| Kit NeoLISA® BioQ
80173700024 |
III | INTERNACIONAL CIENTIFICA LTDA | 12/06/2017 | Until 12/06/2027 |
| GSP NEONATAL BIOTINIDASE KIT
10298910122 |
III | REVVITY DO BRASIL LTDA | 31/03/2014 | Until 31/03/2034 |
| NEO NATAL BIOTINIDASE KIT
10298910092 |
III | REVVITY DO BRASIL LTDA | 14/07/2008 | Until 14/07/2033 |
| KIT NEOLISA BIO
80173700004 |
III | INTERNACIONAL CIENTIFICA LTDA | 26/06/2006 | Until 26/06/2036 |