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CODE 1.

PRODUCT / Format

Full Name

Specimen

Remarks

Rapid tests for Pregnancy & Fertility&Menopause

SN1.1

hCG strip

Human Chorionic Gonadotropin

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN1.2

hCG cassette

Human Chorionic Gonadotropin

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN1.1’

hCG combo strip

Human Chorionic Gonadotropin

Serum / urine

CE compliant to Annex III of European Directive 98/79/EC.

SN1.2’

hCG combo cassette

Human Chorionic Gonadotropin

Serum / urine

CE compliant to Annex III of European Directive 98/79/EC.

SN1.3

LH strip

Luteinizing Hormone

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN1.4

LH cassette

Luteinizing Hormone

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN1.5

FSH strip

Follicle Stimulating Hormone

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN1.6

FSH cassette

Follicle Stimulating Hormone

urine

CE compliant to Annex III of European Directive 98/79/EC.

2.

SN2.2

Rapid tests for Infectious diseases H. Pylori antibody

Helicobacter Pylori

Whole blood/serum/plasma

CE compliant to Annex III of European Directive 98/79/EC.

CE compliant to Annex

SN2.2'

H. Pylori antigen

Helicobacter Pylori

SN2.3

Anti-HIV 1,2 cassette

Human Immunodeficiency Virus 1/2 Antibody

Feces

III of European Directive 98/79/EC

Whole blood/serum/plasma Manufacturer EC Declaration

3.

Tumor Markers rapid tests


SN3.1

AFP strip

Alpha Fetoprotein

Serum / plasma

CE compliant to Annex III of European Directive 98/79/EC.

SN3.2

AFP cassette

Alpha Fetoprotein

Serum / plasma

CE compliant to Annex III of European Directive 98/79/EC.

SN3.3

CEA strip

Carcinoma Embryonic Ag. S/P

Serum / plasma

CE compliant to Annex III of European Directive 98/79/EC.

SN3.4

CEA cassette

Carcinoma Embryonic Ag. S/P

Serum / plasma

CE compliant to Annex III of European Directive 98/79/EC.

SN3.5

PSA strip

Prostate Specific Antigen

Serum/plasma

Manufacturer EC Declaration

SN3.6

PSA cassette

Prostate Specific Antigen

Serum/plasma/Whole blood

Manufacturer EC Declaration

SN3.7

FOB cassette

Fecal Occult Blood

CE compliant to Annex

4.

Feces

III of European Directive 98/79/EC.

Rapid tests for Sexually transmited diseases

SN4.1

Syphilis strip

Treponema Pallidum (TP)

Serum/plasma

CE compliant to Annex III of European Directive 98/79/EC.

SN4.2

Syphilis cassette

Treponema Pallidum (TP)

Serum/plasma

CE compliant to Annex III of European Directive 98/79/EC.

SN4.2'

Syphilis cassette

CE compliant to Annex Treponema Pallidum (TP)

Whole blood/serum/plasma

III of European Directive 98/79/EC.

SN4.4

Gonorrhea cassette

Neisseria Gonorrhoeae

Urogenital secretions

CE compliant to Annex III of European Directive 98/79/EC.

SN4.5

Chlamydia cassette

Chlamydia antigen

Urogenital secretions

Manufacturer EC Declaration

5.

Hepatitis rapid tests

SN5.1

HBsAg strip

Hepatitis B Virus surface Antigen

Serum / plasma

Manufacturer EC Declaration

SN5.2

HBsAg cassette

Hepatitis B Virus surface Antigen

Serum / plasma

Manufacturer EC Declaration

SN5.3

Anti-HCV strip

Hepatitis C Virus Antibody

Serum/plasma

Manufacturer EC Declaration

SN5.4

Anti-HCV

Hepatitis C Virus Antibody

Serum/plasma

Manufacturer EC


cassette

Declaration

SN5.4'

Anti-HCV cassette

Hepatitis C Virus Antibody

SN5.5

Anti-HBs strip

Hepatitis B Virus surface Antibody

Serum / plasma

Manufacturer EC Declaration

SN5.6

Anti-HBs cassette

Hepatitis B Virus surface Antibody

Serum / plasma

Manufacturer EC Declaration

SN5.7

Anti-HBc strip

Hepatitis B Virus core Antibody

Serum / plasma

Manufacturer EC Declaration

SN5.8

Anti-HBc cassette

Hepatitis B Virus core Antibody

Serum / plasma

Manufacturer EC Declaration

6.

Whole blood/serum/plasma

Manufacturer EC Declaration

Cardiac Markers rapid tests

SN6.1

Troponin I cassette

Troponin I

Whole blood/serum/plasma

CE compliant to Annex III of European Directive 98/79/EC.

SN6.2

Myoglobin cassette

Myoglobin

Whole blood/serum/plasma

CE compliant to Annex III of European Directive 98/79/EC.

CE compliant to Annex

SN6.3

CK - MB cassette

Creatin Kinase-MB

Whole blood/serum/plasma

SN6.X.3

3 tests panel

cTnI+CKMB+Myo

Whole blood/serum/plasma

III of European Directive 98/79/EC.

CE compliant to Annex

7.

III of European Directive 98/79/EC.

Rapid tests for DOA (Drugs Of Abuse)

SN7.1

AMP strip/cassette

Amphetamine

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN7.2

BAR strip/cassette

Barbiturates

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN7.3

BZO strip/cassette

Benzodiazepine

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN7.4

COC strip/cassette

Cocaine

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN7.5

MDMA strip/cassette

Methylenedioxymethamphetamine

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN7.6

MET strip/cassette

Methamphetamine

urine

CE compliant to Annex III of European Directive


98/79/EC. SN7.7

MOR strip/cassette

Morphine

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN7.8

MTD strip/cassette

Methadone

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN7.9

OPI strip/cassette

Opiates

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN7.10

TCA strip/cassette

Tricyclic Antidepressants

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN7.11

THC strip/cassette

Tetrahydrocannabinol

urine

CE compliant to Annex III of European Directive 98/79/EC.

SN 7.X

Multi DOA panel

Multi Drug of abuse panels

urine

CE compliant to Annex III of European Directive 98/79/EC.

8.

Rapid tests for Parasitology

8.1

Malaria cassette

Malaria P.f/Pan antigen

whole blood

CE compliant to Annex III of European Directive 98/79/EC.

Pregnancy & Fertility & Menopause rapid tests IVD for professional use Code

Product / format

specimen

package

Shelf life

Sensitivity

Specificity

SN1.1

hCG strip

urine

50 tests/box

24 months

20 mIU/mL

>96%

SN1.2

hCG cassette

urine

30 tests/box

24 months

20 mIU/mL

>96%

SN1.1’

hCG strip

Urine / serum

50 tests/box

24 months

20 mIU/mL

>96%

SN1.2’

hCG cassette

Urine / serum

30 tests/box

24 months

20 mIU/mL

>96%

SN1.3

LH strip

urine

50 tests/box

18 months

30 mIU/mL

99,5%

SN1.4

LH cassette

urine

30

18

30 mIU/mL

99,5%


tests/box

months

SN1.5

FSH strip

urine

50 tests/box

18 months

25 mIU/mL

>99%

SN1.6

FSH cassette

urine

30 tests/box

18 months

25 mIU/mL

>99%

Infectiuos Diseases rapid tests IVD for professional use Code

Product / format

specimen

package

Shelf life

Sensitivity

Specificity

SN2.2

H.Pylori antibody

Whole blood/serum/plasma

30 tests/box

24 months

98%

98%

SN2.2'

H.Pylori antigen

Feces

30 tests/box

24 months

>94%

97%

SN2.3

Anti-HIV 1,2 cassette

Whole blood/serum/plasma

30 tests/box

18 months

>99%

99%

Tumor Markers rapid tests IVD for professional use Code

Product / format

specimen

package

Shelf life

Sensitivity

Specificity

SN3.1

AFP strip

Serum/plasma

50 tests/box

18 months

25 ng/mL

99%

SN3.2

AFP cassette

Serum/plasma

30 tests/box

18 months

25 ng/mL

99%

SN3.3

CEA strip

Serum/plasma

50 tests/box

18 months

5 ng/mL

99%

SN3.4

CEA cassette

Serum/plasma

30 tests/box

18 months

5 ng/mL

99%

SN3.5

PSA strip

Serum/plasma

50 tests/box

18 months

4 ng/mL

98%

SN3.6

PSA cassette

Serum/plasma/Whole blood

30 tests/box

18 months

4 ng/mL

98%

SN3.7

FOB cassette

Feces

30 tests/box

18 months

50 ng/mL

98%


Sexually transmited diseases rapid tests IVD for professional use Code

Product / format

specimen

package

Shelf life

Sensitivity

Specificity

SN4.1

Syphilis strip

Serum/plasma

50 tests/box

18 months

>99%

99%

SN4.2

Syphilis cassette

Serum/plasma

30 tests/box

18 months

>99%

99%

SN4.2'

Syphilis cassette

Whole blood/serum/plasma

30 tests/box

18 months

>99%

99%

SN4.3

Gonorrhea strip

Vaginal/Urethral swabs

50 tests/box

18 months

108bacterial / mL

>99%

SN4.4

Gonorrhea cassette

Vaginal/Urethral swabs

30 tests/box

18 months

1X108CFU/ mL

>99%

SN4.5

Chlamydia cassette

Vaginal/Urethral swabs

30 tests/box

18 months

5X108CFU / mL

97%

Hepatitis rapid tests IVD for professional use Code

Product / format

specimen

package

Shelf life

Sensitivity

Specificity

SN5.1

HBsAg strip

Serum/plasma

50 tests/box

24 months

1ng/mL

98%

SN5.2

HBsAg cassette

Serum/plasma

30 tests/box

24 months

1ng/mL

98%

SN5.3

Anti-HCV strip

Serum/plasma

50 tests/box

18 months

>99%

98%

SN5.4

Anti-HCV cassette

Serum/plasma

30 tests/box

18 months

>99%

98%

SN5.4'

Anti-HCV cassette

Whole blood/serum/plasma

30 tests/box

18 months

>99%

98%

SN5.5

Anti-HBs strip

Serum/plasma

50 tests/box

18 months

20 mIU/mL

99%

SN5.6

Anti-HBs cassette

Serum/plasma

30 tests/box

18 months

20 mIU/mL

99%

SN5.7

Anti-HBc strip

Serum/plasma

50 tests/box

18 months

>99%

99%


SN5.8

Anti-HBc cassette

Serum/plasma

30 tests/box

18 months

>99%

99%

Cardiac Markers rapid tests IVD for professional use Code

Product / format

specimen

package

Shelf life

Sensitivity

Specificity

SN6.1

Troponin I cassette

Whole blood/serum/plasma

30 tests/box

18 months

0,5 ng/mL

98%

SN6.2

Myoglobin cassette

Whole blood/serum/plasma

30 tests/box

18 months

50 ng/mL

99%

SN6.3

CK-MB

Whole blood/serum/plasma

30 tests/box

18 months

7 ng/mL

99%

SN6.X.3

panel cTnI+CKMB+Myo

Whole blood/serum/plasma

30 tests/box

18 months

Drugs of Abuse rapid tests IVD for professional use Code

Product / format

specimen

package

Shelf life

Sensitivity

Specificity

SN7.1

AMP strip/cassette

urine

50/30 tests/box

18 months

1000 ng/mL

97,5%

SN7.2

BAR strip/cassette

urine

50/30 tests/box

18 months

300 ng/mL

97,5%

SN7.3

BZO strip/cassette

urine

50/30 tests/box

18 months

300 ng/mL

95%

SN7.4

COC strip/cassette

urine

50/30 tests/box

18 months

300 ng/mL

97,5%

SN7.5

MDMA strip/cassette

urine

50/30 tests/box

18 months

500 ng/mL

99%

SN7.6

MET strip/cassette

urine

50/30 tests/box

18 months

1000 ng/mL

97,5%

SN7.7

MOR strip/cassette

urine

50/30 tests/box

18 months

300 ng/mL

99%

SN7.8

MTD strip/cassette

urine

50/30 tests/box

18 months

300 ng/mL

97,5%


SN7.9

OPI strip/cassette

urine

50/30 tests/box

18 months

2000 ng/mL

95%

SN7.10

TCA strip/cassette

urine

50/30 tests/box

18 months

1000 ng/mL

93%

SN7.11

THC strip/cassette

urine

50/30 tests/box

18 months

50 ng/mL

>99%

SN 7.X.X

Multi DOA panel

urine

30 tests/box

18 months

99%

Parasitology rapid tests IVD for professional use Code

Product / format

specimen

package

Shelf life

Sensitivity

Specificity

SN8.1

Malaria cassette

Whole blod

30 tests/box

24 months

>99%

>99%


Campmedica product list