CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
Tuning Mix MassChrom® Vitamins B1 and B6 in whole blood 10350840503	Buffers, diluents and other solutions for laboratory analysis	I	BIOSYS LTDA	21/09/2026	Valid
Adjustment Reagent MassChrom Vitamins B1 and B6 in whole blood 10350840504	Buffers, diluents and other solutions for laboratory analysis	I	BIOSYS LTDA	21/09/2026	Valid
Dilution Buffer MassChrom Vitamins B1 and B6 in whole blood 10350840505	Buffers, diluents and other solutions for laboratory analysis	I	BIOSYS LTDA	21/09/2026	Valid
Família MassChrom® Vitamins B1 and B6 in whole blood 10350840500	Combined parameters in one product - class II	II	BIOSYS LTDA	17/08/2026	Valid
Tuning Mix 2 – MassScreen® Amino Acids, Acylcarnitines EXTENDED (non-derivatised) 10350840492	Buffers, diluents and other solutions for laboratory analysis	I	BIOSYS LTDA	12/01/2026	Valid
Multilevel Dried Blood Spot Linearity Set incl. Ado, dAdo 10350840490	Buffers, diluents and other solutions for laboratory analysis	I	BIOSYS LTDA	05/01/2026	Valid
Família MassScreen Amino Acids, Acylcarnitines EXTENDED (non-derivatised) incl. Ado, dAdo 10350840489	Combined parameters in one product (III) - newborn screening	III	BIOSYS LTDA	29/12/2025	Until 29/12/2035
Tuning Mix 1 – MassScreen® Amino Acids, Acylcarnitines EXTENDED (non-derivatised) 10350840488	Buffers, diluents and other solutions for laboratory analysis	I	BIOSYS LTDA	01/12/2025	Valid
Família VMA, HVA, 5-HIAA in urine 10350840481	Combined parameters in one product - class III	III	BIOSYS LTDA	07/07/2025	Until 07/07/2035
Família Antiepileptic Drugs in serum/plasma 10350840480	Combined parameters in one product - class III	III	BIOSYS LTDA	30/06/2025	Until 30/06/2035
Família Trileptal, Zonisamida 10350840478	Combined parameters in one product - class III	III	BIOSYS LTDA	23/06/2025	Until 23/06/2035
Vitamins A and E in serum/plasma 10350840453	Combined parameters in one product - class II	II	BIOSYS LTDA	25/03/2024	Valid
Internal Standard Set - MassTox Immunosuppressants in Whole Blood 10350840441	Combined parameters in one product - class III	III	BIOSYS LTDA	02/01/2024	Until 02/01/2034
Família Vitamin B6 in plasma/serum 10350840435	Vitamin B6	II	BIOSYS LTDA	15/05/2023	Valid
Tuning Mix - MassChrom amino acids and acylcarnitines – analytes and Internal Standards (non derivatised) 10350840425	Buffers, diluents and other solutions for laboratory analysis	I	BIOSYS LTDA	13/10/2022	Valid
FAMÍLIA MassChrom Amino Acid Analysis in plasma/serum 10350840419	Amino acids - newborn screening	III	BIOSYS LTDA	14/04/2022	Until 14/04/2032
Família MassChrom Cortisol, Cortisone In Saliva 10350840420	Combined parameters in one product - class II	II	BIOSYS LTDA	14/04/2022	Valid
FAMÍLIA o-cresol, p-cresol, phenol in urine - HPLC 10350840411	Combined parameters in one product - class II	II	BIOSYS LTDA	02/09/2021	Valid
Família 1-hydroxypyrene in urine 10350840412	1-Hydroxypyrene	II	BIOSYS LTDA	02/09/2021	Valid
Família controles e calibradores 25-OH-Vitamin D3/D2 10350840406	Combined parameters in one product - class II	II	BIOSYS LTDA	20/05/2021	Valid
Família Tuning Mix - succinylacetone 10350840394	Amino acids	II	BIOSYS LTDA	25/02/2021	Valid
Familia amino acids analysis 10350840393	Amino acids - newborn screening	III	BIOSYS LTDA	11/02/2021	Until 11/02/2031
Familia MassChrom amino acids and acylcarnitines – succinylacetone 10350840383	Amino acids - newborn screening	III	BIOSYS LTDA	01/10/2020	Until 01/10/2030
INTERNAL STANDARD SEROTONIN 10350840366	Serotonin	II	BIOSYS LTDA	15/06/2020	Valid
Família Steroid Panel 2 10350840356	Combined parameters in one product - class II	II	BIOSYS LTDA	10/02/2020	Valid
FAMÍLIA Steroid Panel 1 10350840357	Combined parameters in one product - class II	II	BIOSYS LTDA	10/02/2020	Valid
FAMÍLIA MassTox TDM Serie A Parameter Set Benzodiazepines 2 in serum/plasma 10350840354	Combined parameters in one product - class II	II	BIOSYS LTDA	11/11/2019	Valid
Família Internal Standard – MassChrom Amino Acids And Acylcarnitines from Dried Blood 10350840352	Amino acids - newborn screening	III	BIOSYS LTDA	21/10/2019	Until 21/10/2029
FAMÍLIA MassTox TDM Serie A Parameter Set Benzodiazepines 1 in serum/plasma 10350840351	Combined parameters in one product - class II	II	BIOSYS LTDA	07/10/2019	Valid
MassTox TDM Series A Basic kit 10350840349	Buffers, diluents and other solutions for laboratory analysis	I	BIOSYS LTDA	01/04/2019	Valid
FAMÍLIA Masstox TDM Serie A Parameter Set – Antimycotic Drugs/EXTENDED in serum/plasma 10350840346	Combined parameters in one product - class II	II	BIOSYS LTDA	18/02/2019	Valid
FAMÍLIA IMMUNOSUPPRESSANTS IN WHOLE BLOOD – ONE MINUTE TEST - AUTO 10350840343	Combined parameters in one product - class III	III	BIOSYS LTDA	03/12/2018	Until 03/12/2028
TRILEPTAL IN SERUM CALIBRATOR 10350840324	Combined parameters in one product - class II	II	BIOSYS LTDA	30/07/2018	Valid
SISTEMA HPLC CHROMSYSTEMS 10350840326	Chromatography analyzer	II	BIOSYS LTDA	30/07/2018	Valid
Catecholamines Urine Calibration Standard 10350840327	Catecholamines (noradrenaline, adrenaline, dopamine and derivatives)	II	BIOSYS LTDA	30/07/2018	Valid
Vitamins A/E Serum Calibration Standard 10350840328	Combined parameters in one product - class II	II	BIOSYS LTDA	30/07/2018	Valid
CONTROLE BENZODIAZEPINICOS BI-NIVEL I + II 10350840329	Combined parameters in one product - class II	II	BIOSYS LTDA	30/07/2018	Valid
Pregabalin / Vigabatrin / Gabapentin in Serum Calibrator 10350840331	Combined parameters in one product - class II	II	BIOSYS LTDA	30/07/2018	Valid
Serum controls – Pregabalin / Vigabatrin / Gabapentim - Bi - Level (Level I+II) 10350840332	Combined parameters in one product - class II	II	BIOSYS LTDA	30/07/2018	Valid
PLASMA CONTROL HOMOCYSTEINE BI-NIVEL I +II 10350840333	Homocysteine	II	BIOSYS LTDA	30/07/2018	Valid
25-OH-Vitamin D3/D2 Serum Calibration Standard 10350840334	Combined parameters in one product - class II	II	BIOSYS LTDA	30/07/2018	Valid
Homocysteine Plasma Calibration Standard 10350840335	Homocysteine	II	BIOSYS LTDA	30/07/2018	Valid
Metanephrines Urine Calibration Standard 10350840336	Metanephrine	III	BIOSYS LTDA	30/07/2018	Until 13/04/2036
FAMÍLIA VITAMINS B1 AND B6 IN WHOLE BLOOD – AUTOMATED SAMPLE PREPARATION - UHPLC 10350840309	Combined parameters in one product - class II	II	BIOSYS LTDA	05/03/2018	Valid
FAMÍLIA ITRACONAZOLE, POSACONAZOLE, VORICONAZOLE IN SERUM/PLASMA - HPLC 10350840304	Combined parameters in one product - class II	II	BIOSYS LTDA	23/10/2017	Valid
FAMÍLIA T, T-MUCONIC ACID IN URINE 10350840302	Muconic acid	II	BIOSYS LTDA	14/08/2017	Valid
Família Masschrom Steroids in serum/plasma 10350840294	Combined parameters in one product - class II	II	BIOSYS LTDA	27/03/2017	Valid
Masscheck Methylmalonic Acid Plasma Control, Bi-Level (I+II) 10350840273	Methylmalonic acid (MMA)	II	BIOSYS LTDA	17/08/2015	Valid
3Plus1 Multilevel Plasma Calibrator Set Methylmalonic Acid 10350840272	Methylmalonic acid (MMA)	II	BIOSYS LTDA	10/08/2015	Valid
Família de Controles – Plasma Endocrine Control 10350840271	Combined parameters in one product - class III	III	BIOSYS LTDA	11/05/2015	Until 16/03/2036

CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH

Brazilian registration holders

Device types

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