IFU for IVDR Certified Products - Download Page

Date of Revision: 10th September 2026

 

[Reagents]

 

OC-SENSOR FIT Products

Class C

OC-Auto Sampling Bottle 3

Class A

OC-Auto Sampling Bottle 4

Class A

OC-Light S FIT Products

Class C

OC-FCa Products

Class B

LAMP Products

Class C / Class A

 

[Instruments – Operation Manuals]

 

OC-SENSOR PLEDIA

Class A

OC-SENSOR Ceres

Class A

OC-SENSOR R70

Class A

 

 

 

 

OC-SENSOR FIT Products

Product Name

REF

IFU No.

Issue Date

OC-SENSOR FIT Latex Reagent

for OC-SENSOR DIANA, PLEDIA

for OC-SENSOR io

for OC-SENSOR MICRO

 

V-PZ01

V-PH18

V-PH33

380362-C (Latest)

EN / IT / ES / FR / DE / PT 

 

380362-A (VOID)

 

2026/05/31

 

 

2022/05/26

OC-SENSOR FIT Buffer

for OC-SENSOR DIANA, PLEDIA

for OC-SENSOR MICRO, io

 

V-PZ03

V-PH46

OC-SENSOR FIT

for OC-SENSOR Ceres

for OC-SENSOR R70

 

V-PH01

V-PZ05

OC-FIT Calibrator

for OC-SENSOR MICRO, DIANA

for OC-SENSOR io, PLEDIA

for OC-SENSOR Ceres

 

V-PH51

V-PH52

V-PH02

380363-C (Latest)

EN / IT / ES / FR / DE / PT 

 

380363-A (VOID)

 

2026/05/31

 

 

2022/05/26

OC-FIT Control

LV1

LV2

LV3

 

V-PH53

V-PH54

V-PH59

380365-C (Latest)

EN / IT / ES / FR / DE / PT

 

380365-A (VOID)

 

2026/05/31

 

 

2022/05/26

OC-SENSOR Sample Diluent

for OC-SENSOR PLEDIA, MICRO, io

for OC-SENSOR Ceres

 

V-PH19

V-PH08

380364-C (Latest)

EN / IT / ES / FR / DE / PT

 

380364-A (VOID)

 

2026/05/31

 

 

2022/05/26

 

 

OC-Auto Sampling Bottle 3

Product Name

REF

IFU No.

Issue Date

OC-Auto Sampling Bottle 3

for OC-SENSOR Series

with barcode

without barcode

 

 

V-PZ25

V-PZ26

340026A-H (Latest)

EN / IT / ES / FR / DE / PT

 

340026A-G (VOID)

 

2026/02/02

 

 

2022/04/01

 

 

 

OC-Auto Sampling Bottle 4

Product Name

REF

IFU No.

Issue Date

OC-Auto Sampling Bottle 4

for OC-SENSOR Series

with barcode

 

 

 

 

without barcode

 

 

VCPZ45

VCPZ47

VCPZ52

VCPZ54

VCPZ56

VCPZ46

VCPZ50

VCPZ51

341843-A (Latest)

EN / IT / ES / FR / DE

2026/02/02

 

 

OC-Light S FIT Products

Product Name

REF

IFU No.

Issue Date

OC-Light S FIT

Test Strips

Sampling Bottles

 

V-PC52

V-PH82

341760A-C (Latest)

EN / IT

 

341760A-B (VOID)

 

2022/05/26

 

 

2021/11/15

 

 

 

OC-FCa Products

Product Name

REF

IFU No.

Issue Date

OC-FCa Reagent

 

 

V-PH11

V-PH09

380316-E (Latest)

EN / IT / ES / FR / DE

 

380316-C (VOID)

 

2022/05/26

 

 

2022/05/26

OC-FCa Calibrator

 

 

V-PH12

380317-E (Latest)

EN / IT / ES / FR / DE

 

380317-C (VOID)

 

2026/05/31

 

 

2022/05/26

OC-FCa Control

LV1

LV2

LV3

 

V-PH13

V-PH14

V-PH15

380318-E (Latest)

EN / IT / ES / FR / DE

 

380318-C (VOID)

 

2026/05/31

 

 

2022/05/26

 

 

LAMP Products

Product Name

REF

IFU No.

Issue Date

Loopamp™ MTBC Detection Kit

(English/French/Spanish/German)

 

 

972000

380236-D (Latest)

EN / ES / FR / DE

 

2023/10/31

 

 

Loopamp™ PURE DNA Extraction Kit

(English/French/Spanish/German)

 

970000

380237-C (Latest)

EN / ES / FR / DE

 

2022/03/01

 

Loopamp™ Malaria Pan Detection Kit

(English/French/Spanish/German)

 

9740000

380239-D (Latest)

EN / ES / FR / DE

 

2023/6/23

 

Loopamp™ Malaria Pv Detection Kit

(English/French/Spanish/German)

 

975000

380263-C (Latest)

EN / ES / FR / DE

 

2023/6/23

 

Loopamp™ Malaria Pan Detection Kit

(English/French/Spanish/German)

 

977000

380270-C (Latest)

EN / ES / FR / DE

 

2023/6/23

 

Loopamp™ Malaria Pf Detection Kit

(English/French/Spanish/German)

 

978000

380273-C (Latest)

EN / ES / DE

 

2023/6/23