IBL International GmbH

Address:FLUGHAFENSTRASSE, 52A,HAMBURG,DE

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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, Progesterone (JLS) (4) Radioimmunoassay, Testosterones And Dihydrotestosterone (CDZ) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Calibrator, Secondary (JIT) (2) Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking (NST) (2) Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) (JKC) (1) Enzyme Immunoassay, Cortisol, Salivary (NHG) (1)

Premarket Exempt

No Yes

Clear

Acetylcholine Receptor Autoantibodies (ARAb) RRA - 04049325001404 Catalog Number : RE21021

Device Description : Acetylcholine Receptor Autoantibodies (ARAb) RRA Assay Kit - 100 determinations

Device Class : 2

Duns Number: 312694785

Premarket Exempt : No

Product Code : NST

Prescription Use : Yes

Device Count : 1

Acetylcholine Receptor Autoantibodies (ARAb) RRA - 04049325001428 Catalog Number : RE21023

Device Description : Acetylcholine Receptor Autoantibodies (ARAb) RRA Assay Kit - 30 determinations

Device Class : 2

Duns Number: 312694785

Premarket Exempt : No

Product Code : NST

Prescription Use : Yes

Device Count : 1

DHEA-S ELISA - 04049325001787 Catalog Number : RE52181

Device Description : DHEA-S ELISA - 96 Determinations

Device Class : 1

Duns Number: 312694785

Premarket Exempt : Yes

Product Code : JKC

Prescription Use : No

Device Count : 1

Progesterone Luminescence Immunoassay - 04049325003521 Catalog Number : RE62021

Device Description : Progesterone Luminescence Immunoassay - 96 Determinations

Device Class : 1

Duns Number: 312694785

Premarket Exempt : No

Product Code : JLS

Prescription Use : Yes

Device Count : 1

Progesterone Luminescence Immunoassay - 04049325003538 Catalog Number : RE62029

Device Description : Progesterone Luminescence Immunoassy - 10 x 96 Determinations

Device Class : 1

Duns Number: 312694785

Premarket Exempt : No

Product Code : JLS

Prescription Use : Yes

Device Count : 1

Testosterone Luminescence Immunoassay - 04049325003545 Catalog Number : RE62031

Device Description : Testosterone Luminescence Immunoassay - 96 Determinations

Device Class : 1

Duns Number: 312694785

Premarket Exempt : No

Product Code : JIT, CDZ, JJX

Prescription Use : Yes

Device Count : 1

SaliCaps - 04049325003606 Catalog Number : RE69991.

Device Description : SaliCaps - 100 Tubes

Device Class : 1

Duns Number: 312694785

Premarket Exempt : No

Product Code : JLS

Prescription Use : Yes

Device Count : 1

SaliCaps - 04049325003613 Catalog Number : RE69995.

Device Description : SaliCaps - 500 Tubes

Device Class : 1

Duns Number: 312694785

Premarket Exempt : No

Product Code : JLS

Prescription Use : Yes

Device Count : 1

Testosterone Luminescence Immunoassay - 04049325006546 Catalog Number : RE62039.

Device Description : Testosterone Luminescence Immunoassay - 10 x 96 Determinations

Device Class : 1

Duns Number: 312694785

Premarket Exempt : No

Product Code : JIT, CDZ, JJX

Prescription Use : Yes

Device Count : 1

Cortisol Saliva Luminescence Immunoassay - 04049325007727 Catalog Number : RE62111

Device Description : Cortisol Saliva Luminescence Immunoassay Assay Kit - 96 Determinations

Device Class : 2

Duns Number: 312694785

Premarket Exempt : No

Product Code : NHG

Prescription Use : Yes

Device Count : 1

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