KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950 Telepon : (021) 5201590 Pesawat 2029, 8011

Faksimile : (021) 52964838 Kotak Pos : 203

Catatan:

- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1

Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.

- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.

Berdasarkan Peraturan Menteri Kesehatan R.I Nomor 62 Tahun 2017 Tentang Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro Dan Perbekalan Kesehatan Rumah Tangga dengan ini diberikan persetujuan untuk diedarkan dengan :

NOMOR IZIN EDAR A L A T K E S E H A T A N

KEMENKES RI AKL 30305411636

Nama Dagang / Merek : SD BIOLINE HIV 1/2 3.0 Kelompok / Kelas Resiko : Diagnostik In Vitro / D

Kategori Produk : Peralatan Imunologi dan Mikrobiologi Sub Kategori : Sistem Tes Imunologikal

Jenis Produk : Multiple autoantibodies immunological test system.

Tipe / Ukuran : Ref. No. 03FK16; 03FK10 dan 03FK11 Kemasan : Dus, kit, isi 25, 30 dan 100 tes

Nama Produsen / Pabrikan : STANDARD DIAGNOSTICS INC., Korea

Melalui ALERE INTERNATIONAL LIMITED., Ireland Nama Pendaftar : PT. ALERE HEALTH, DKI Jakarta

Atas dasar lisensi dari : - Ketentuan

1. Persetujuan izin edar berlaku sampai dengan 13 Desember 2023.

2. Wajib menyampaikan laporan berkala dan laporan jika ada kejadian yang tidak diinginkan akibat penggunaan Alat Kesehatan tersebut di atas sesuai ketentuan berlaku.

3. Izin edar ini merupakan persetujuan perpanjangan dari Nomor Izin Edar Alat Kesehatan KEMENKES RI AKL 30305411636 tanggal 2 Desember 2016. Dengan demikian izin edar sebelumnya dinyatakan tidak berlaku.

4. Kit dapat di gunakan sebagai skrining produk darah, diagnosa awal dan untuk surveilans pada infeksi HIV.

5. Apabila dikemudian hari ada pihak lain yang berhak atas merek dan/atau keagenan produk tersebut, pendaftar bersedia mengembalikan izin edar.

6. Penandaan dan informasi produk yang terlampir merupakan bagian yang tidak terpisahkan dari persetujuan izin edar ini.

7. Apabila di kemudian hari terdapat kekeliruan, maka persetujuan izin edar ini akan ditinjau kembali.

Jakarta, 20 Desember 2019

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DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950 Telepon : (021) 5201590 Pesawat 2029, 8011

Faksimile : (021) 52964838 Kotak Pos : 203

Catatan:

- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1

Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.

- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.

LAMPIRAN

NOMOR IZIN EDAR

ALAT KESEHATAN

KEMENKES RI AKL 30305411636

No. Deskripsi Tipe / Kode

1 - -

Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk deskripsi dan tipe / kode produk yang tercantum dalam lampiran ini

Powered by TCPDF (www.tcpdf.org)

Jakarta, 20 Desember 2019

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PANTONE 1505 C Size : 182 x 125 x 71mm

30Tests/kit

ONE STEP Anti-HIV 1/2 TEST

For in vitro dia

gnostic use only C until expira Store at 1~30

tion date

1)

30 Test devices individually foil pouched with a desiccant 2)

Assay diluent (1 x 4ml/vial)

3) 1 Instructions for use

HIV 1/2 3.0 �

03FK10-40-3

One Step, Ra pid, Immunochroma tographic test for the detection of

anti - HIV 1/2 in Human Serum, Plasma or Whole Blood

1 / 03FK10

For in vitro diagnostic use only Store at 1~30C until expiration date

HIV�1/2 3.0

65, Boraha gal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of K

orea www.standardia.com [email protected]

TEST PROCEDURE

10µl of Serum or Plasma (20µl of Whole blood)

4 drops of assay diluent

10~20 minutes

Caution

Time to result is 10 to 20 minutes. After adding the diluent, read the result after 10 minutes but not more than 20 minutes. If the test result is not legible after 10 minutes due to high background color, read again later but within 20 minutes of adding the diluent. Do not read after 20 minutes.

Un paso, rapido, test inmunocromatografico para la detección de anti HIV 1/2 en suero plasma o sangre total

30 Pruebas/kit

Teste rápido, imunocromatográfico, para a detecção do anti-HIV 1/2 em amostra de soro, plasma ou sangue total humano

30 Testes/kit

Test rapide par immunochromatographique en une étape, pour la détection de Anti HIV 1/2 dans le sérum humain, plasma ou sang Total

Kit de 30 tests

Réservé exclusivement à un usage diagnostique in vitro Stocker à une température comprise entre 1 et 30ºC jusqu’à la date d’expiration

Sólo para uso de diagnóstico in vitro

Almacene de 1-30ºC hasta la fecha de expiración Apenas para utilização em diagnóstico in vitro Conservar entre 1 e 30ºC até à data de expiração do prazo de validade

PT ES

FR

Test de HIV 1/2 en une étape Test HIV 1/2 en un paso Teste Rápido Anti-HIV 1/2

CONTENIDO :

1) 30 Dispositivos de prueba en bolsas individuales con un disecante

2) Diluyentes del ensayo (1 x 4ml/vial) 3) 1 Instrucciones de uso

CONTEÚDO :

1) 30 Dispositivos de teste embalados individualmente numa bolsa de alumínio com um dessecante 2) Diluentes do ensaio (1 x 4ml/frasco) 3) 1 Instruções de utilização CONTENU :

1) 30 Cassettes-tests emballées individuellement avec un agent déshydratant

2) Diluants de test (1 x 4ml/flacon) 3) 1 Mode d’emploi

Negative Invalid HIV 2 Positive HIV 1 Positive

Interpretation of the test

Strong

Medium

Weak When 3 lines appear

Strong

Medium

If line “1” is darker than line “2”, it should be interpreted as HIV-1 positive only. (Not HIV-2 positive)

30Tests/kit

ONE STEP Anti-HIV 1/2 TEST

For in vitro diagnostic use only Store at 1~30C until expiration date

HIV � 1/2 3.0

HIV�1/2 3.0

Precautions / Kit storage and stability

1. The test device should be stored at 1~30°C. Do not freeze the kit or components.

2. The test device is sensitive to humidity as well as to heat. 3. Perform the test immediately after removing the test device from foil

pouch.

4. Do not use it beyond the expiration date. 5. The shelf-life of the kit is as indicated on outer package. 6. Do not use the test kit if the pouch is damaged or the seal is broken. 7. Check the desiccant for color change of the humidity indicator and to

throw away the pouch if the color indicates saturation. 8. Do not re-use the test device.

9. The test device is recommended to use at room temperature (15~30°C).

Warnings

1. For in vitro diagnostic use only.

2. Do not eat or smoke while handling specimens. 3. Wear protective gloves while handling specimens. Wash hands

thoroughly afterward. 4. Avoid splashing or aerosol formation.

5. Clean up spills thoroughly using an appropriate disinfectant. 6. Decontaminate and dispose of all specimens, reaction kits and

potentially contaminated materials, as if they were infectious waste, in a biohazard container.

7. Do not mix and interchange different specimen.

8. Anticoagulants such as heparin, EDTA and sodium citrate do not affect the test result.

9. Use of hemolytic samples, rheumatoid factors-contained samples and lipidemic, icteric samples can lead to impair the test results.

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100Tests/kit

ONE STEP Anti-HIV 1/2 TEST

For in vitro dia

gnostic use only C until expira Store at 1~30

tion date

1)

10 Multi-device tests with desiccant in individual foil pouch x 10 2)

Assay diluents (2 x 8.5ml/vial)

3) 1 Instructions for use

HIV-1/2 3.0 (Multi)

For in vitro diagnostic use only Store at 1~30C until expiration date

HIV-1/2 3.0 (Multi) HIV-1/2 3.0 (Multi)

03FK11-20-14

orea www.standardia.com [email protected]

One step, ra pid, immunochroma tographic test for the simultaneous,

qualitative detection of all antibod y isotypes (IgG, IgM,

IgA) specific to

HIV-1 including subtype-O and HIV-2 in human serum, plasma or whole blood

100Tests/kit

ONE STEP Anti-HIV 1/2 TEST

For in vitro diagnostic use only Store at 1~30C until expiration date

HIV-1/2 3.0 (Multi)

03FK11

For in vitro diagnostic use only Store at 1~30C until expiration date

경기도 용인시 기흥구 보라하갈로 65

전문의약품 100Tests/kit

■ 원료약품의

1) 1회 검사용 디바이스 중

골드접합체 : 유전자재조합 HIV1 / HIV2 항원 (*)액 - 접합 골드 콜로이드...1±0.2㎍

검사선 1 : 유전자재조합 HIV1 (*) 항원액...0.625±0.125㎍

검사선 2 : 유전자재조합 HIV2 (*) 항원액...0.5±0.1㎍

대조선 : 산양 항 유전자 재조합 HIV 항원에 대한 항체액 (**)...

...0.75±0.15㎍

나이트로셀룰로스 막...25±5×4.5±0.9mm 콘쥬게이트 패드...7±1.4×4.5±0.9mm 검체 패드...18±3.6×4.5±0.9mm 흡수 패드...18±3.6×4.5±0.9mm 플라스틱 카세트

* 유전자재조합 HIV1 (*) 항원액 : gp41 포함 항원, p24 포함 항원 혼합액

* 유전자재조합 HIV2 (*) 항원액 : gp36 포함 항원액

** 유전자재조합 HIV 항원액으로 산양을 면역시켜 얻은 항체액

2) 검체희석액 (2 x 8.5ml/병)

50mM 트리스-염산완충액...8.5ml 아지드화나트륨...적량

■ 사람의 혈청, 혈장 및 전혈 (정맥혈, 모세혈) 중의

사람면역 결핍바이러스 (HIV : Human Immunodeficiency Virus)의 type 1과 2형 (HIV-1, HIV-2)에 대한 항체 검출

■ 100 테스트 / 킷트

■ 기밀용기, 실온보관 (1~30℃)

■ _{등 자세한 것은}

설명서를 참조하여 주십시오.

■

에스디 에치아이브이

PN: 03FK11-20-14 Date of Last Revision: 2015/04/21

HIV 1/2 3.0 (M)100T Pac

Box, 100 Test

Size : 222 x 125 x 71mm

Black PMS 208 C PMS 1505C

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Negative Invalid HIV 2 Positive HIV 1 Positive

PANTONE 1505 C PANTONE 208 C Size : 182 x 125 x 71mm

25Tests/kit

ONE STEP Anti-HIV 1/2 TEST

For in vitro dia

gnostic use only C until expira Store at 1~30

tion date

1) 25 Test devices individually foil pouched with a desiccant

2)

Assay diluent (1 x 4ml/vial) 3)

25 20µl Capillary pipettes, 25 Lancets, 25

Alcohol swabs 1 Instructions for use 4)

Figure 2 : Lancet Figure 1 : Micropipette

Interpretation of the test

HIV 1/2 3.0 �

03FK16-40-2

One Step, Ra pid, Immunochroma tographic test for the detection of

anti - HIV 1/2 in Human Serum, Plasma or Whole Blood

1 / 03FK16

For in vitro diagnostic use only Store at 1~30C until expiration date

HIV�1/2 3.0

orea

www.standardia.com [email protected]

Un paso, rapido, test inmunocromatografico para la detección de anti HIV 1/2 en suero plasma o sangre total

25 pruebas/kit

Teste rápido, imunocromatográfico, para a detecção do anti-HIV 1/2 em amostra de soro, plasma ou sangue total humano

25 Testes/kit

Test rapide par immunochromatographique en une étape, pour la détection de Anti HIV 1/2 dans le sérum humain, plasma ou sang Total

Kit de 25 tests Réservé exclusivement à un usage diagnostique in vitro Stocker à une température comprise entre 1 et 30ºC jusqu’à la date d’expiration

Sólo para uso de diagnóstico in vitro

Almacene de 1-30ºC hasta la fecha de expiración Apenas para utilização em diagnóstico in vitro Conservar entre 1 e 30ºC até à data de expiração do prazo de validade

PT ES

FR

Test de HIV 1/2 en une étape Test HIV 1/2 en un paso Teste Rápido Anti-HIV 1/2

CONTENIDO :

1) 25 Dispositivos de prueba en bolsas individuales con un disecante

2) Diluyentes del ensayo (1 x 4ml/vial)

3) 25 pipetas capilares 20µl, 25 lancetas, 25 hisopos de alcohol

4) 1 Instrucciones de uso

CONTEÚDO :

1) 25 Dispositivos de teste embalados individualmente numa bolsa de alumínio com um dessecante

2) Diluentes do ensaio (1 x 4ml/frasco)

3) 25 pipetas capilares de 20µl, 25 lancetas, 25 cotonete embebido em álcool

4) 1 Instruções de utilização CONTENU :

1) 25 Cassettes-tests emballées individuellement avec un agent déshydratant

2) Diluants de test (1 x 4ml/flacon) 3) 25 pipettes capillaires 20µl, 25 lancettes,

25 compresse d’alcool 4) 1 Mode d’emploi

10µl of Serum or Plasma (or 20µl of Whole blood)

4 drops of Assay diluent

Clean the area to be lanced with an alcohol swab.

Add 20µl of drawn blood

Add 4 drops of Assay diluent Pierce with a sterile lancet

provided. Collect Blood to Black line

of Capillary pipette

TEST PROCEDURE

Strong

Medium

Strong

Medium

25Tests/kit

ONE STEP Anti-HIV 1/2 TEST

For in vitro diagnostic use only Store at 1~30C until expiration date

HIV � 1/2 3.0

HIV�1/2 3.0

Precautions / Kit storage and stability

1. The test device should be stored at 1~30°C. Do not freeze the kit or components.

2. The test device is sensitive to humidity as well as to heat. 3. Perform the test immediately after removing the test device from foil

pouch.

4. Do not use it beyond the expiration date. 5. The shelf-life of the kit is as indicated on outer package. 6. Do not use the test kit if the pouch is damaged or the seal is broken. 7. Check the desiccant for color change of the humidity indicator and to

throw away the pouch if the color indicates saturation. 8. Do not re-use the test device.

9. The test device is recommended to use at room temperature (15~30°C).

Warnings

1. For in vitro diagnostic use only.

2. Do not eat or smoke while handling specimens. 3. Wear protective gloves while handling specimens. Wash hands

thoroughly afterward. 4. Avoid splashing or aerosol formation.

5. Clean up spills thoroughly using an appropriate disinfectant. 6. Decontaminate and dispose of all specimens, reaction kits and

potentially contaminated materials, as if they were infectious waste, in a biohazard container.

7. Do not mix and interchange different specimen.

8. Anticoagulants such as heparin, EDTA and sodium citrate do not affect the test result.

9. Use of hemolytic samples, rheumatoid factors-contained samples and lipidemic, icteric samples can lead to impair the test results.

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YYYY.MM.DD

Mfg : YYYY.MM.DD

BL02N

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C T C 2 1 HIV 1/2 HIV 1/2

PN: 03FK11-P2-8

Date of Last Revision:

2016/06/21 SD BIOLINE HIV-1/2 3.0(M)

Zipper bag - 해외용

Size : 216 x 125mm

PMS 208C

Black PMS 1505C

For in vitro diagnostic use only Store at 1 - 30 ºC sealed

03FK11-P2-8

HIV-1/2 3.0

1°C 30°C

ONE STEP Anti-HIV1/2 TEST 10 Tests

Divide device as occasion demands 1

Wait 10 - 20 minutes

Dispense 10 µl serum or 3 plasma (20 µl of whole blood) + 4 drops (about 120 µl) of assay diluent.

2 Test interpretation Negative

Positive

Invalid

Die line Do not print

C T C2 1

HIV 1/2HIV 1/2

C T C2 1

HIV 1/2HIV 1/2

C T C2 1

HIV 1/2HIV 1/2

C T C2 1

HIV 1/2HIV 1/2

C T C2 1

HIV 1/2HIV 1/2

C T C2 1

HIV 1/2HIV 1/2

C T C2 1

HIV 1/2HIV 1/2

C T C2 1

HIV 1/2HIV 1/2

C T 2C 1 HIV 1/2 HIV 1/2

C T C2 1 HIV 1/2

HIV 1/2

C T

C 2 1

HIV 1/2 HIV 1/2

C T C 2 1

1/2

HIV 1/2 HIV 1/2

C T C 2 1

HIV 1/2 HIV 1/2

C T C 2 1

HIV 1/2 HIV 1/2

C T C 2 1

HIV 1/2 HIV 1/2

C T C 2 1

HIV 1/2 HIV 1/2

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SD BIOLINE HIV-1/2 3.0

A. Isi 30

B. Isi 25

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA