Actim Oy

Address:Klovinpellontie 3,Espoo Uusimaa,FI

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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

Immunoassay, Insulin-Like Growth Factor Binding Protein-1 (OAM) (2)

Premarket Exempt

Clear

Actim PROM Controls - 06430030990622 Catalog Number :

Device Description : The Actim PROM Controls kit consists of one of each of the following components: The Actim PROM Controls kit consists of one of each of the following components:1. Actim PROM Negative Control (0 μg/L)2. Actim PROM Low Positive Control (40 μg/L)3. Actim PROM High Positive Control (250 μg/L)4. Actim Reconstitution Solution5. Instructions for use

Device Class : 1

Duns Number: 368646046

Premarket Exempt : No

Product Code : OAM

Prescription Use : Yes

Device Count : 1

Actim PROM - 06430030990714 Catalog Number :

Device Description : Actim PROM test pouch. Each pouch includes:- One tube of Specimen Extraction Sol Actim PROM test pouch. Each pouch includes:- One tube of Specimen Extraction Solution (0.5 mL). This phosphate-buffered solution contains bovine serum albumin (BSA), protease inhibitors and preservatives.- One dipstick in a sealed aluminum foil pouch with desiccant.- One sterile polyester swab for specimen collection.

Device Class :

Duns Number: 368646046

Premarket Exempt : No

Product Code : OAM

Prescription Use : Yes

Device Count : 1

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