Wallac Oy

Address:MUSTIONKATU 6,TURKU Varsinais-Suomi,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

General Purpose Reagent (PPM) (4) Fluorometer, For Clinical Use (KHO) (3) Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (LXG) (2) Shaker/Stirrer (JRQ) (1)

Premarket Exempt

No Yes

Clear

DELFIA Diluent I - 06438147009749 Catalog Number : B127-100

Device Description : For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

DELFIA Diluent I - 06438147009756 Catalog Number : B128-100

Device Description : For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

DELFIA Diluent II - 06438147009763 Catalog Number : B131-100

Device Description : For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

DELFIA Diluent II - 06438147009770 Catalog Number : B132-100

Device Description : For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

Wallac DBS Puncher - 06438147013890 Catalog Number : 1296-071

Device Description : Wallac 1296-071 DBS Puncher is a microprocessor controlled automatic puncher for Wallac 1296-071 DBS Puncher is a microprocessor controlled automatic puncher for DELFIA® tests performed on filter paper in microplate format. It punches out a disk from a bloodspot on filter paper; this disk then falls into a microtitration well. Punch disk size depends on the punch head installed. Up to 99 disks can be punched into the same well. When the selected number of disks has been punched for a well, the plate is moved to the next position so that the next disk(s) can be punched out. Up to two plates can be loaded to DBS puncher. A microtitration 96-well format plate and Corning Costar deep well tray can be loaded at the same time. Plates consisting of twelve eight-well strips are also supported.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : Yes

Device Count : 1

Wallac Plate Shake - 06438147064540 Catalog Number : 1296-004

Device Description : 1296-004 DELFIA® Plateshake is intended to be used with DELFIA reagents but can 1296-004 DELFIA® Plateshake is intended to be used with DELFIA reagents but can also be used for other applications where shaking of microtitration plates is required. One to four plates can be on the shaker simultaneously.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : Yes

Product Code : JRQ

Prescription Use : Yes

Device Count : 1

DELFIA Platewash - 06438147064564 Catalog Number : 1296-026

Device Description : 1296-026 DELFIA Platewash is a washer designed for automatic washing of microtit 1296-026 DELFIA Platewash is a washer designed for automatic washing of microtitration strips or plates. It is self-contained, having built-in pumps for vacuum and dispensing and supplied with all the bottles and tubing needed for operation. For use with DELFIA analytes, ready-made programs are accessible.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1

VICTOR2 D - 06438147116126 Catalog Number : 1420-020

Device Description : VICTOR2 D will primarly be used for measuring test kits supplied by Wallac espec VICTOR2 D will primarly be used for measuring test kits supplied by Wallac especially for neonatal tests. Secondly VICTOR2 D can also be used for other measurements of TRF and prompt fluorescence. The user is a laboratory running screening on newborns or a general clinical chemistry lab running different hormones on blood samples.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : Yes

Product Code : KHO

Prescription Use : Yes

Device Count : 1

AutoDELFIA Plate Processor - 06438147116133 Catalog Number : 1235-001

Device Description : Used with 1235-501 AutoDELFIA® Plate Processor System or 1235-514 Fully Automati Used with 1235-501 AutoDELFIA® Plate Processor System or 1235-514 Fully Automatic DELFIA® System

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : KHO

Prescription Use : No

Device Count : 1

AutoDELFIA Sample Processor - 06438147116157 Catalog Number : 1297-014

Device Description : Used with 1235-514 Fully Automatic DELFIA® System

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : KHO

Prescription Use : No

Device Count : 1

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