KMLTTB Validated Reagents and Equipments

ID Validation Number Approved Name IVD Class IVD Type Batch Number Size/Weight Vendor Manufacturer/Supplier
1 validation_number approved_name ivd_class ivd_type batch_number size_weight vendor manufacturer_supplier
2 KMLTTB/POC/000010 BIOELISA HBs Ag 3.0 BIOKIT S.A OPTI MEDICAL E.A LTD
3 KMLTTB/POC/000011 BIOELISA SYPHILLIS 3.0 BIOKIT S.A OPTI MEDICAL E.A LTD
4 KMLTTB/POC/000012 BIOELISA HCV 4.0 BIOKIT S.A OPTI MEDICAL E.A LTD
5 KMLTTB/POC/000013 SAMBA 1 HIV QUAL TEST DIAGNOSTICS FOR THE REAL WORLD DIAGNOSTICS FOR THE REAL WORLD
6 KMLTTB/POC/000014 SICKLE SCAN BM-SCS-PI-006.P BIOMEDOMICS INC MEDOMIX CONCEPT LIMITED
7 KMLTTB/POC/000015 KHB COLLOIDAL GOLD HIV (1+2)V2 SHANGHAI KEHUA BIO ENGINEERING CO LTD TOYO INTERNATIONAL
8 KMLTTB/POC/000016 S.D BIOLINE MALARIA RDT STANDARD DIAGNOSTICS INC STANDARD DIAGNOSTICS INC
9 KMLTTB/POC/000017 BD FACS PRESTO TM NEAR- PATIENT CD4 COUNTER BECTON DICKINSON BECTON DICKINSON
10 KMLTTB/POC/000018 BIOELISA HIV 1+2 AG/AB BIOKIT S.A STEPLABS TECHNICAL SERVICES LTD
11 KMLTTB/POC/000019 BIOELISA SYPHILIS 3.0 BIOKIT S.A STEPLABS TECHNICAL SERVICES LTD
12 KMLTTB/POC/000020 BIOELISA HCV 4.0 BIOKIT S.A STEPLABS TECHNICAL SERVICES LTD
13 KMLTTB/POC/000021 BIOELISA HBs Ag 3.0 BIOKIT S.A STEPLABS TECHNICAL SERVICES LTD
14 KMLTTB/POC/000022 INTECH PRODUCTS INC,ANTI BODY A IN TEC PRODUCTS INC AFYA TECH ENTERPRISES
15 KMLTTB/POC/000023 INTEC PRODUCTS INC,ANTI BODY B IN TEC PRODUCTS INC AFYA TECH ENTERPRISES
16 KMLTTB/POC/000024 INTEC PRODUCTS INC,ANTI BODY D IN TEC PRODUCTS INC AFYA TECH ENTERPRISES
17 KMLTTB/POC/000025 HIV-SYPHILIS DUO TEST STANDARD DIAGNOSTICS INC STANDARD DIAGNOSTICS INC
18 KMLTTB/POC/000026 ACUPOWER EXISTATION HIV VIRAL LOAD & EID BIONEER CORPORATION VALUE DIAGNOSTICS
19 KMLTTB/POC/000027 STANDARD Q MALARIA P.F AG RDT SD BIOSENSOR STEPLABS TECHNICAL SERVICES LTD
20 KMLTTB/POC/000028 ALERE TM Q HIV-1/2 DETECT ALERE TECHNOLOGIES GMBH ULTRA LAB E.A LIMITED
21 KMLTTB/POC/000029 XPERT HIV-I QUAL CEPHEID AB CAROGA DIAGNOSTICS LIMITED
22 KMLTTB/POC/000030 HIV (1+2) ANTIBODY COLLOIDAL GOLDV2 SHANGHAI KEHUA BIO ENGINEERING CO LTD TOYO INTERNATIONAL
23 KMLTTB/POC/000031 RAPID TEST FOR ANTIBODY TO HUMAN IMMUNODEFICIENCY VIRUS (COLLOIDAL GOLD DEVICE) BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO LTD PRECISE BIOTECH LIMITED
24 KMLTTB/POC/000032 INSTI HIV SELF TEST BIOLYTICAL LABORATORIES INC VALUE DIAGNOSTICS LIMITED
25 KMLTTB/POC/000033 INSTI HIV SELF TEST BIOLYTICAL LABORATORIES INC VALUE DIAGNOSTICS LIMITED
26 KMLTTB/POC/000034 PANTHER SYSTEM HOLOGIC INC MEDIONICS HEALTHCARE LIMITED
27 KMLTTB/POC/000036 INSTI HIV - 1/2 ANTIBODY TEST KIT KIT BIOLYTICAL LABORATORIES INC
28 KMLTTB/POC/000038 ALERE DETERMINE TM HBsAg ACCESS ALLIANCE LTD ALERE MEDICAL CO LTD
29 KMLTTB/POC/000039 CHEMBIO DPP SYPHILLIS SCREEN AND CONFIRM ASSAY CHEMBIO DIAGNOSTIC SYSTEM INC FARAM EAST AFRICA LIMITED
30 KMLTTB/POC/000040 I-STAT 1(MODEL 300W) ZIWALA LIMITED ABBOT POINT OF CARE INC
31 KMLTTB/POC/000041 I-STAT 1(MODEL 300W)(BLOOD GLUCOSE) ZIWALA LIMITED ABBOT POINT OF CARE INC
32 KMLTTB/POC/000042 I-STAT 1(MODEL 300W)(BLOOD GAS ANALYSIS PCO2) ZIWALA LIMITED ABBOT POINT OF CARE INC
33 KMLTTB/POC/000043 I-STAT 1(MODEL 300W)(BLOOD GAS ANALYSIS BE) ZIWALA LIMITED ABBOT POINT OF CARE INC
34 KMLTTB/POC/000044 I-STAT 1(MODEL 300W)(BLOOD GAS ANALYSIS PH) ZIWALA LIMITED ABBOT POINT OF CARE INC
35 KMLTTB/POC/000045 I-STAT 1(MODEL 300W)(BLOOD GAS ANALYSIS HCO3) ZIWALA LIMITED ABBOT POINT OF CARE INC
36 KMLTTB/POC/000046 I-STAT 1(MODEL 300W) (BLOOD GAS ANALYSIS SO2) ZIWALA LIMITED ABBOT POINT OF CARE INC
37 KMLTTB/POC/000047 I-STAT 1(MODEL 300W) (ELECTROLYTE NA+,K,CL) ZIWALA LIMITED ABBOT POINT OF CARE INC
38 KMLTTB/POC/000048 I-STAT 1(MODEL 300W) (HCT,HB) ZIWALA LIMITED ABBOT POINT OF CARE INC
39 KMLTTB/POC/000049 I-STAT 1(MODEL 300W) (UREA & CREATININE) ZIWALA LIMITED ABBOT POINT OF CARE NC
40 KMLTTB/POC/000050 CARESTAT -HRP-2 SAI PHARMACEUTICALS LIMITED ACCESS BIO INC
41 KMLTTB/POC/000051 ORAQUICK HIV SELF TEST ANJIWA CO LTD ORASURE TECHNOLOGIES INC
42 KMLTTB/POC/000052 AQUOIS CL FLOW CYTOMETRY SYSTEM EXCELLA BIOTECHNOLOGIES LIMITED BECKMAN COULTER
43 KMLTTB/POC/000053 MICO/NANOBIOSYS ULTRA FAST SAMPLE PREP & ULTRA FAST LAB CHIP REAL-TIME PCR SYSTEM LENGUE LIMITED MICOBIOMED CO LTD
44 KMLTTB/POC/000054 MICO/NANOBIOSYS ULTRA FAST SAMPLE PREP & ULTRA FAST LAB CHIP REAL-TIME PCR SYSTEM LENGUE LIMITED MICOBIOMED CO LTD
45 KMLTTB/POC/000055 MICO/NANOBIOSYS ULTRA FAST SAMPLE PREP & ULTRA FAST LAB CHIP REAL-TIME PCR SYSTEM LENGUE LIMITED MICOBIOMED CO LTD
46 KMLTTB/POC/000056 MICO/NANOBIOSYS ULTRA FAST SAMPLE PREP & ULTRA FAST LAB CHIP REAL-TIME PCR SYSTEM LENGUE LIMITED MICOBIOMED CO LTD
47 KMLTTB/POC/000057 MICO/NANOBIOSYS ULTRA FAST SAMPLE PREP & ULTRA FAST LAB CHIP REAL-TIME PCR SYSTEM LENGUE LIMITED MICOBIOMED CO LTD
48 KMLTTB/POC/000058 CARESTAT -HRP-2/PLDH SAI PHARMACEUTICALS LIMITED ACCESS BIO INC
49 KMLTTB/POC/000062 BIOSURE HIV SELF TEST BIOLYTICA AFRICA LIMITED BIOSURE (UK) LIMITED
50 KMLTTB/POC/000063 BLOOD STASIS TM 21 DNA/RNA MAGBIO GENOMICS SOLUTIONS AFRICA LIMITED MAGBIO GENOMICS INC
51 KMLTTB/POC/000064 SURE CHECK HIV SELF TEST SURGIPATH SERVICES E.A LIMITED CHEMBIO DIAGNOSTIC SYSTEMS INC
52 KMLTTB/POC/000065 PARAHIT F VER 1.0 RAPID TEST FOR P.FALCIPARUM MALARIA-DEVICE (TROPICALISED) PYRAMID PHARMA LIMITED ARKRAY HEALTHCARE PVT LTD
53 KMLTTB/POC/000067 ATOMO HIV SELF TEST (GALILEO PLATFORM) HIGHRIDGE PHARMACEUTICALS LIMITED ATOMO DIAGNOSTICS PTY LTD
54 KMLTTB/POC/000069 STANDARD-Q HBSAG STEPLABS TECHNICAL SERVICES LTD SD BIOSENSOR
55 KMLTTB/POC/000070 ALERE DETERMINE TB LAM AG TEST ULTRA LAB E.A LTD ALERE TECHNOLOGIES GMBH
56 KMLTTB/POC/000072 HUMALOOP T CHEM-LABS LIMITED EIKEN CHEMICAL CO LTD
57 KMLTTB/POC/000075 WONDFO SARS-COV-2 ANTIBODY TEST SURGILINKS GUANGZHOU WONDFO BIOTECH CO LTD
58 KMLTTB/POC/000078 STANDARD Q HIV/SYPHILIS COMBO STEPLABS TECHNICAL SERVICES LTD SD BIOSENSOR
59 KMLTTB/POC/000079 STANDARD Q MALARIA P.F AG RDT STEPLABS TECHNICAL SERVICES LTD SD BIOSENSOR
60 KMLTTB/POC/000080 STANDARD Q HIV 1/2 AB 3- LINE STEPLABS TECHNICAL SERVICES LTD SD BIOSENSOR
61 KMLTTB/POC/000081 COVID-19 IGG/IMG RAPID TEST MGA GC PROJECTS KENYA LTD MULTI-G BVBA - LANGE LEEMSTRAAT
62 KMLTTB/POC/000082 ZYBIO SARS-COV-2 RT-PCR J & K INVESTMENT (K) LTD ZYBIO INC
63 KMLTTB/POC/000085 DIAGNOSTICS AUTOMATION SARS-COV-2 RT PCR ALFAJIRI PHARMACEUTICALS LTD DIAGNOSTIC AUTOMATION / CORTEZ DIAGNOSTICS INC
64 KMLTTB/POC/000087 SD BIOLINE HIV/SYPHILLIS DUO ULTRA LAB E.A LTD ABBOT DIAGNOSTICS KOREA INC
65 KMLTTB/POC/000088 COVID-19 VTM REVITAL HEALTHCARE (EPZ) REVITAL HEALTHCARE (EPZ) LIMITED REVITAL HEALTHCARE (EPZ) LIMITED
66 KMLTTB/POC/000089 MEDOPTICS LIMITED MEDOPTICS LIMITED MEDOPTICS LIMITED
67 KMLTTB/POC/000092 SD MALARIA AG PF ULTRA LAB E.A LTD ABBOT DIAGNOSTICS KOREA INC
68 KMLTTB/POC/000093 MALARIA AG PF TEST ULTRA LAB E.A LTD ABBOT DIAGNOSTICS KOREA INC
69 KMLTTB/POC/000096 ONE STEP HIV 1/2 WHOLE BLOOD/SERUM PLASMA TEST ACHELIS KENYA LIMITED GUANGZHOU WONDFO BIOTECH CO LTD
70 KMLTTB/POC/000097 PANBIO COVID-19 AG RAPID TEST DEVICE (NASOPHARYNGE) ULTRA LAB E.A LTD ABBOT RAPID DIAGNOSTICS
71 KMLTTB/POC/000116 ALTONA DIAGNOSTICS GMBH REALSTAR SARS-COV-2 RT PCR EXCELLA BIOTECHNOLOGIES LIMITED ALTONA DIAGOSTICS GBH
72 KMLTTB/POC/000117 HIV 1/2 STAT PAK ASSAY SURGIPATH SERVICES E.A LIMITED CHEMBIO DIAGNOSTIC SYSTEMS INC
73 KMLTTB/POC/000124 ABBOT PANBIO COVID RAPID TEST DEVICE (NASAL) ULTRA LAB E.A LTD ABBOT RAPID DIAGNOSTICS
74 KMLTTB/POC/000126 RAPID RESPONSE CORONAVIRUS AG RAPID TEST CASSETTE KITS WADEN CONNECTIONS LIMITED BTNZ INC
75 KMLTTB/POC/000127 MA-1610 ISOTHERMAL FLUORESCENCE Q PCR WADEN CONNECTIONS LIMITED SUZHOU MOLARRAY CO LTD
76 KMLTTB/POC/000128 MA-1600 SERIES ISOTHERMAL FLUORESCENCE Q PCR WADEN CONNECTIONS LIMITED SUZHOU MOLARRAY CO LTD
77 KMLTTB/POC/000129 TIANAMP VIRUS RNA KIT DP 315-R-TB-200 PREPS BIOZEQ (K) LTD TIANGEN BIOTECH (BEIJING) CO LTD
78 KMLTTB/POC/000130 COVID-19 SPEED ANTIGEN TEST SPEED TEST AFRICA LTD BIOSPEEDIA
79 KMLTTB/POC/000131 VIVA DIAG SARS-COV-2 AG RAPID TEST J & K INVESTMENT (K) LTD SK - TELEMED GMBH
80 KMLTTB/POC/000133 ACRO COVID-19 ANTIGEN RAPID TEST MIPET (K) LIMITED ACRO BIOTECH INC
81 KMLTTB/POC/000134 PCL COVID-10 ANTIGEN GOLD BIOQUEST KENYA LIMITED PCL INC
82 KMLTTB/POC/000135 EXCALIBUR RAPID SARS-COV-2 ANTIGEN TEST KILIMANI CHILDREN'S CLINIC EXCALIBUR HEALTHCARE SERVICES
83 KMLTTB/POC/000136 ZYBIO SARS-COV-2 ANTIGEN ASSAY KIT J & K INVESTMENT (K) LTD ZYBIO INC
84 KMLTTB/POC/000137 LUMIRA DX COVID-19 SARS-COV-2 ANTIGEN TEST ROI SCIENTIFIC LIMITED LUNIRA DX UK LTD
85 KMLTTB/POC/000138 VIROKEY SARS-COV-2 RT-PCR TEST BIOZEQ (K) LTD VELA OPERATIONS SINGAPORE PTE LTD
86 KMLTTB/POC/000139 ZYBIO SARS-COV-2 ANTIGEN ASSAY KIT J & K INVESTMENT (K) LTD ZYBIO INC
87 KMLTTB/POC/000140 VITASSAY QPCR SARS-COV-2 DETECTION KIT KETON CONSULTING LTD VITASSAY HEALTHCARE
88 KMLTTB/POC/000141 ACCUPOWER SARS-COV-2 MULTIPLEX REAL-TIME RT-PCR KIT KIT CHANGE BIOTEC LIMITED BIONEER CORPORATION
89 KMLTTB/POC/000143 NEWGENE BIOENGINEERING COVID-19 ANTIGEN RAPID KIT KIT ACCORD MEDICAL SUPPLIES LTD NEW GENE(HANGZHOU) BIOENGINEERING CO LTD
90 KMLTTB/POC/000144 ALLPLEX 2019-N COV ASSAY KIT INQABA BIOTEC E.A LTD SEEGENE INC
91 KMLTTB/POC/000145 FLUOROCARE SARS-COV-2 SPIKE PROTEIN TEST KIT SAM-TECH DIAGNOSTICS CO LTD SHENZHEN MICROPROFIT BIOTECH CO LTD
92 KMLTTB/POC/000146 NEWGENE BIOENGINEERING COVID-19 ANTIGEN KIT NITRON INVESTMENTS LIMITED NEW GENE(HANGZHOU) BIOENGINEERING CO LTD
93 KMLTTB/POC/000148 HELIX I-SARS-COV-2 AG RAPID TEST EDUMART ENTERPRISE LTD CELLEX BIOTECH(SUZHOU) LTD
94 KMLTTB/POC/000150 GP (SARS-COV-2 ANTIGEN) THE HEART CLINIC PHARMACY LTD GETEIN BIOTECH,INC
95 KMLTTB/POC/000151 EDINBURGH GENETICS ACTIVE XPRESS+ COVID-19 AG RAPID KIT CA MEDYLYNKS KENYA LIMITED EDINBURGH GENETICS LIMITED
96 KMLTTB/POC/000152 COVIRAT SARS- COV-2 ANTIGEN SAI PHARMACEUTICALS LIMITED ZEPHYR BIOMEDICALS,A DIVISION OF TULIP DIAGNOSTICS (P) LTD
97 KMLTTB/POC/000153 CADY SARS COV-2 ANTIGEN RAPID TEST KIT KIT REVITAL HEALTHCARE (EPZ) LIMITED REVITAL HEALTHCARE (EPZ) LIMITED
98 KMLTTB/POC/000154 INDICAID COVID-19 RAPID ANTIGEN TEST EXL BUSINESS GROUP LIMITED PHASE SCIENTIFIC INTERNATIONAL LTD
99 KMLTTB/POC/000155 VISITECT CD4 ADVANCED DISEASE SCIENCE SCOPE LTD OMEGA DIAGNOSTICS LTD
100 KMLTTB/POC/000157 R TEST COVID-19 Q PCR ALLPLEX KIT M TRADE LIMITED MULTIPLEX DX S.R.O
101 KMLTTB/POC/000158 PISHTAZ TEB SARS COV 2 ANTIGEN RAPID TEST M TRADE LIMITED PISHTAZ TEB ZAMAN DIAGNOSTICS
102 KMLTTB/POC/000159 GA COV-2 ANTIGEN RAPID THE HEART CLINIC PHARMACY LTD GETEIN BIOTECH,INC
103 KMLTTB/POC/000161 M-PIMA HW- 1/2 DETECT ULTRA LAB E.A LTD ABBOT RAPID DIAGNOSTICS
104 KMLTTB/POC/000162 NX TEX ELIMINATE MALARIA PF ULTRA LAB E.A LTD ABBOT DIAGNOSTICS
105 KMLTTB/POC/000163 KIAMGENICS NOVEL CORONAVIRUS DETECTION KIT KIT AMBER MEDICAL CLINICS LTD NEW GENE(HANGZHOU) BIOENGINEERING CO LTD
106 KMLTTB/POC/000164 STRONGSTEP SARS COV-2 ANTIGEN RAPID TEST ADOLA LABORATORIES NANJING LIMING BIO-PRODUCTS CO LTD
107 KMLTTB/POC/000165 MEDSAN SARS COV-2 ANTIGEN RAPID TEST TRACEJACK LIMITED MEDSAN GMBH
108 KMLTTB/POC/000166 DETERMINE HBS AG 2 TEST ACCESS ALLIANCE HEALTHCARE LIMITED ABBOTT JAPAN CO LTD
109 KMLTTB/POC/000167 CRAG LFA CRYPTOCOCCAL ANTIGEN LATERAL FLOW ESSAY JESTECH DIAGNOSTICS LIMITED IMMY-2701 CORPORATE CENTRE
110 KMLTTB/POC/000169 REAL-TIME FLOURESCENCE QUANTITATIVE PCR UNIT MODEL X960A ,X960B TRIO DIAGNOSTIC LTD
111 KMLTTB/POC/000175 SARS COV-2 ANTIGEN RAPID TEST KIT (IMMUNOCHROMATOGRAPHY) THE HEART CLINIC PHARMACY LTD LABNOVATION TECHNOLOGIES INC
112 KMLTTB/POC/000176 NOVEL CORONA VIRUS (SARS-COV-2 FAST NUCLEIC ACID DETECTION KIT) SAGITARIX LIMITED JIANG SU COWIN BIOTECH CO LTD
113 KMLTTB/POC/000177 SURE STATUS COVID-19 ANTIGEN CARD TEST MEDLABS LIMITED PREMIER MEDICAL CORPORATION PRIVATE LIMITED
114 KMLTTB/POC/000178 BIO-SPEEDY DIRECT RT -QPCR SARS-COV-2 BOJI MEDICAL LOGISTICS LTD BIOEKSEN R & D TECHNOLOGIES INC
115 KMLTTB/POC/000179 GENBODY COVID-19 AG GREAT SOUTHERN GROUP LIMITED GENBODY INC
116 KMLTTB/POC/000180 TRUENET MTB RT - PCR KIT STEPLABS TECHNICAL SERVICES LTD MOLBIO DIAGNOSTICS PRIVATE LIMITED
117 KMLTTB/POC/000181 TRUENET COVID-19 CHIP BASED RT PCR TEST KIT KIT STEPLABS TECHNICAL SERVICES LTD MOLBIO DIAGNOSTICS PRIVATE LIMITED
118 KMLTTB/POC/000182 TRUELAB UNO DX STEPLABS TECHNICAL SERVICES LTD MOLBIO DIAGNOSTICS PRIVATE LIMITED
119 KMLTTB/POC/000185 SARS COV-2 ANTIGEN & INFLUENZA A/B RAPID TEST KITS KIT THE HEART CLINIC PHARMACY LTD LABNOVATION TECHNOLOGIES INC
120 KMLTTB/POC/000188 TRINSCREEN HIV GAMMAZENITH KENYA LIMITED TRINITY BIOTECH PLC