IFU for IVDR Certified Products - Download Page

Date of Revision: 1st October 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-E (Latest)

EN / ES / FR / DE

 

380236-D (VOID)

 

2026/08/01

 

 

2023/10/31

Loopamp™ PURE DNA Extraction Kit

(English/French/Spanish/German)

 

970000

380237-D (Latest)

EN / ES / FR / DE

 

380237-C (VOID)

 

2026/08/01

 

 

2022/03/01

Loopamp™ Malaria Pan Detection Kit

(English/French/Spanish/German)

 

974000

380239-E (Latest)

EN / ES / FR / DE

 

380239-D (VOID)

 

2026/08/01

 

 

2023/6/23

Loopamp™ Malaria Pv Detection Kit

(English/French/Spanish/German)

 

975000

380263-D (Latest)

EN / ES / FR / DE

 

380263-C (VOID)

 

2026/08/01

 

 

2023/6/23

Loopamp™ Malaria Pan Detection Kit

(English/French/Spanish/German)

 

977000

380270-D (Latest)

EN / ES / FR / DE

 

380270-C (VOID)

 

2026/08/01

 

 

2023/6/23

Loopamp™ Malaria Pf Detection Kit

(English/French/Spanish/German)

 

978000

380273-D (Latest)

EN / ES / FR / DE

 

380273-C (VOID)

 

2026/08/01

 

 

2023/6/23

 

 

 

 

Instruments – Operation Manuals

Product Name

REF

IFU No.

Issue Date

OC-SENSOR PLEDIA

 

 

 

 

MV5H00

 

Normal Mode

NN1-1384 (English) Rev.21

(file size 67MB)

NN1-1384 (IT) Rev.05

(file size 30MB)

NN1-1384 (ES) Rev.05

(file size 30MB)

NN1-1384 (FR) Rev.05

(file size 30MB)

NN1-1384 (DE) Rev.05

(file size 37MB)

NN1-1384 (PT) Rev.01

(file size 117MB)

 

Multiple Mode

NN1-1703 (English) Rev.09

(file size 56MB)

 

Multiple Mode

NN1-1703 (Spanish) Rev.01

(file size 28MB)

 

 

2026/Jul.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2026/Jul.

 

 

 

2025/Nov.

2026/Aug.

OC-SENSOR Ceres

  

 

MV5K00

 

NN1-1741 (English) Rev.12

(file size 48MB)

NN1-1741 (IT) Rev.06

(file size 19MB)

NN1-1741 (ES) Rev.06

(file size 18MB)

NN1-1741 (FR) Rev.06

(file size 18MB)

NN1-1741 (DE) Rev.06

(file size 19MB)

 

 

2026/Jul.

 

 

OC-SENSOR R70

  

 

MV5P00

 

(English) Rev.02

(file size 72MB)

(IT) Rev.01

(file size 72MB)

(ES) Rev.01

(file size 72MB)

(FR) Rev.01

(file size 72MB)

(DE) Rev.01

(file size 72MB)

(PT) Rev.01

(file size 72MB)

 

 

2026/Aug.