SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0198-071-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
MP Diagnostics HIV Blot 2.2
Assay Type
IA - Immunoblot
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Directive 98/79/EC: Product design examination certificate, Annex IV.4
Applicant organization
MP Biomedicals Asia Pacific Pte.Ltd.
2 Pioneer Place
Singapore,
627885
Singapore
Pathogen
HIV
Specimen Type
Plasma
Serum
Product Code
Identification name
11030-018
Test kit package size
18
Test Package Size
ANTIGEN STRIPS - Nitrocellulose Strips: 18 or 36 strips
CONTROL NEGATIVE - Non-reactive control: 1 vial (80 μl)
CONTROL POSITIVE - STRONG REACTIVE CONTROL: 1 vial (80 μl)
CONTROL WEAK - WEAK REACTIVE CONTROL: 1 vial (80 μl)
STOCK BUFFER CONCENTRATE (10x): 1 bottle (20 ml)
WASH BUFFER CONCENTRATE (20x): 1 bottle (70 ml)
CONJUGATE: 1 vial (160 μl)
SUBSTRATE: 1 bottle (100 ml)
BLOTTING POWDER: 10 packets (1g each)
Incubation Tray, 9 wells each: 2 or 4 trays
Instructions for Use: 1 piece
Forceps: 1 pair
CONTROL NEGATIVE - Non-reactive control: 1 vial (80 μl)
CONTROL POSITIVE - STRONG REACTIVE CONTROL: 1 vial (80 μl)
CONTROL WEAK - WEAK REACTIVE CONTROL: 1 vial (80 μl)
STOCK BUFFER CONCENTRATE (10x): 1 bottle (20 ml)
WASH BUFFER CONCENTRATE (20x): 1 bottle (70 ml)
CONJUGATE: 1 vial (160 μl)
SUBSTRATE: 1 bottle (100 ml)
BLOTTING POWDER: 10 packets (1g each)
Incubation Tray, 9 wells each: 2 or 4 trays
Instructions for Use: 1 piece
Forceps: 1 pair
Identification name
11030-036
Test kit package size
36
Test Package Size
ANTIGEN STRIPS - Nitrocellulose Strips: 18 or 36 strips
CONTROL NEGATIVE - Non-reactive control: 1 vial (80 μl)
CONTROL POSITIVE - STRONG REACTIVE CONTROL: 1 vial (80 μl)
CONTROL WEAK - WEAK REACTIVE CONTROL: 1 vial (80 μl)
STOCK BUFFER CONCENTRATE (10x): 1 bottle (20 ml)
WASH BUFFER CONCENTRATE (20x): 1 bottle (70 ml)
CONJUGATE: 1 vial (160 μl)
SUBSTRATE: 1 bottle (100 ml)
BLOTTING POWDER: 10 packets (1g each)
Incubation Tray, 9 wells each: 2 or 4 trays
Instructions for Use: 1 piece
Forceps: 1 pair
CONTROL NEGATIVE - Non-reactive control: 1 vial (80 μl)
CONTROL POSITIVE - STRONG REACTIVE CONTROL: 1 vial (80 μl)
CONTROL WEAK - WEAK REACTIVE CONTROL: 1 vial (80 μl)
STOCK BUFFER CONCENTRATE (10x): 1 bottle (20 ml)
WASH BUFFER CONCENTRATE (20x): 1 bottle (70 ml)
CONJUGATE: 1 vial (160 μl)
SUBSTRATE: 1 bottle (100 ml)
BLOTTING POWDER: 10 packets (1g each)
Incubation Tray, 9 wells each: 2 or 4 trays
Instructions for Use: 1 piece
Forceps: 1 pair
IVD Manufacturing Site(s)
MP Biomedicals Asia Pacific Pte.Ltd.
2 Pioneer Place
Singapore,
627885
Singapore