ACTIM OY

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1000212994	1000212994	ACTIM OY	1	N	2026-01-01	Klovinpellontie 3 Espoo Uusimaa FI FI-02180
3013143953	3013143953	Actim Oy Manufacturing Site	1	N	2026-01-01	Noljakantie 13, , Joensuu Pohjois-Karjala FI FI-80130

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
177233	1545790632	K123986	ACTIM PROM	OAM	2014-01-09
201873	1545790632	K123986	ACTIM PROM	OAM	2014-01-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OAM	2	2014-01-09

GUDID#

Actim PROM Controls - 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

Actim Oy

2019-02-28

Actim PROM - 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.

Actim Oy

2019-02-28

Actim PROM - 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.

Actim Oy

2019-02-28