IBL International GmbH

Address:FLUGHAFENSTRASSE, 52A,HAMBURG,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Radioimmunoassay, Estradiol (CHP) (3) Enzyme Immunoassay, Cortisol, Salivary (NHG) (1) Radioassay, Vitamin B12 (CDD) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

Cortisol Saliva Luminescence Immunoassay - 04049325007734 Catalog Number : RE62119

Device Description : Cortisol Saliva Luminescence Immunoassay Assay Kit - 10x96 Determinations

Device Class : 2

Duns Number: 312694785

Premarket Exempt : No

Product Code : NHG

Prescription Use : Yes

Device Count : 1

Active-B12 (Holotranscobalamin) ELISA - 04049325008304 Catalog Number : AX53101

Device Description : Active-B12 (Holotranscobalamin) ELISA - 96 determinations

Device Class : 2

Duns Number: 312694785

Premarket Exempt : No

Product Code : CDD

Prescription Use : Yes

Device Count : 1

17beta-Estradiol Saliva Luminescence Immunoassay - 04049325012356 Catalog Number : RE62141

Device Description : 17beta-Estradiol Saliva Luminescence Immunoassay - 96 Determinations

Device Class : 1

Duns Number: 312694785

Premarket Exempt : Yes

Product Code : CHP

Prescription Use : No

Device Count : 1

17beta-Estradiol Saliva Luminescence Immunoassay - 04049325012363 Catalog Number : RE62149

Device Description : 17beta-Estradiol Saliva Luminescence Immunoassay - 10 x 96 Determinations

Device Class : 1

Duns Number: 312694785

Premarket Exempt : Yes

Product Code : CHP

Prescription Use : No

Device Count : 1

Unassayed Testosterone QC Material - 04049325014879 Catalog Number : 30108902

Device Description : Unassayed Testosterone QC Material - 20 mL

Device Class : 1

Duns Number: 312694785

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

17beta-Estradiol Saliva ELISA - 04049325017214 Catalog Number : 30121045

Device Description : 17beta-Estradiol Saliva ELISA - 96 Determinations

Device Class : 1

Duns Number: 312694785

Premarket Exempt : Yes

Product Code : CHP

Prescription Use : No

Device Count : 1

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