SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0485-013-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Determine Syphilis TP
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
Syphilis RDT
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Abbott Diagnostics Medical Co., Ltd. (Formely: Alere Medical Co. Ltd.)
357 Matsuhidai, Chiba-ken
Matsudo-shi,
270-2214
Japan
Pathogen
Syphilis
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
7D2452
Test kit package size
30
Test Package Size
7D2452 - 30 test/kit
10x tests x 3 sheets - test card
7D2453 - 100 tests/kit
10 tests x 10 sheets - test card
7D2453SET - 100 tests/kit
10 tests x 10 sheets - test card
1 bottle (2
10x tests x 3 sheets - test card
7D2453 - 100 tests/kit
10 tests x 10 sheets - test card
7D2453SET - 100 tests/kit
10 tests x 10 sheets - test card
1 bottle (2
Identification name
7D2453
Test kit package size
100
Test Package Size
7D2452 - 30 test/kit
10x tests x 3 sheets - test card
7D2453 - 100 tests/kit
10 tests x 10 sheets - test card
7D2453SET - 100 tests/kit
10 tests x 10 sheets - test card
1 bottle (2
10x tests x 3 sheets - test card
7D2453 - 100 tests/kit
10 tests x 10 sheets - test card
7D2453SET - 100 tests/kit
10 tests x 10 sheets - test card
1 bottle (2
Identification name
7D2453SET
Test kit package size
100
Test Package Size
7D2452 - 30 test/kit
10x tests x 3 sheets - test card
7D2453 - 100 tests/kit
10 tests x 10 sheets - test card
7D2453SET - 100 tests/kit
10 tests x 10 sheets - test card
1 bottle (2
10x tests x 3 sheets - test card
7D2453 - 100 tests/kit
10 tests x 10 sheets - test card
7D2453SET - 100 tests/kit
10 tests x 10 sheets - test card
1 bottle (2