Other / Antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes.

SOLIRIS IS A THERAPY SPECIFICALLY TESTED…

SOLIRIS IS A THERAPY SPECIFICALLY TESTED AND APPROVED FOR THE TREATMENT OF PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) AN ULTRA-RARE LIFE THREATENING BLOOD DISORDER.

SOLIRIS HAS BEEN APPROVED FOR THE TREATMENT OF PATIENTS WITH PNH IN NEARLY 50 COUNTRIES WORLDWIDE.

SOLIRIS 300MG/30ML IS A FORMULATION OF ECULIZUMAB WHICH IS RECOMBINANT HUMANIZED MONOCLONAL LGG2/4;&#954 ANTIBODY PRODUCED BY MURINE MYELOMA CELL CULTUREAND PURIFIED BY STANDARD BIOPROCESS TECHNOLOGY.

ECULIZUMAB CONTAINS HUMAN CONSTANT REGIONS FROM HUMAN IMMUNOGLOBULIN G2 SEQUENCES AND HUMAN IMMUNOGLOBULIN G4 SEQUENCES AND MURINE COMPLEMENTARITY DETERMINING REGIONS GRAFTED ONTO THE HUMAN FRAMEWORK LIGHT AND HEAVY CHAIN VARIABLE REGIONS.

ECULIZUMAB IS COMPOSED OF TWO 448 AMINO ACID HEAVY CHAINS AND TWO 214 AMINO ACID LIGHT CHAINS AND HAS A MOLECULAR WEIGHT OF APPROXIMATELY 148 KDA.

SOLIRIS 300 MG/30ML IS A STERILE COLOURLESS PRESERVATIVE-FREE SOLUTION FOR INTRAVENOUS INFUSION AND IS SUPPLIED IN 30ML SINGLE USE VIALS.

THE PRODUCT IS FORMULATED AT PH7 AND EACH VIAL CONTAINS 300 MG OF ECULIZUMAB 13.8 MG SODIUM PHOSPHATE MONOBASIC. 53.4 MG SODIUM PHOSPHATE DIBASIC 263.1 MG SODIUM CHLORIDE, 6.6 MG POLYSORBATE 80 (VEGETABLE ORIGIN) AND WATER FOR INJECTION.

THE DP AND FP ARE SUPPLIED IN VIALS, HOWEVER BDS IS SUPPLIED IN 100L BAGS . THE COMPOSITION OF THE PRODUCT IS THE SAME WHETHER BDS DP OR FP.

Classification justification: CLASSIFICATION HAS BEEN DETERMINED IN ACCORDANCE WITH THE FOLLOWING :- GENERAL INTERPRETATIVE RULES (GIRs) GIR 1 HAS BEEN USED TO CLASSIFY THIS PRODUCT BY THE TERMS OF HEADING 3002: HUMAN BLOOD, ANIMAL BLOOD PREPARED FOR THE THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC USES; ANTISERA AND OTHER BLOOD FRACTIONS AND MODIFIED IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; VACCINES, TOXINS,CULTURES OF MICRO-ORGANISMS (EXCLUDING YEASTS) AND SIMILAR PRODUCTS.

GIR 3B HAS BEEN USED AS THE ECULIZUMAB IS THE ESSENTIAL CHARACTER. GIR 5B HAS BEEN USED TO IDENTIFY THE TYPE OF PACKAGING - VIALS AND 100L BAGS.

GIR 6 HAS BEEN USED TO CLASSIFY THE GOODS TO SUBHEADING LEVEL 300210 : ANTISERA AND OTHER BLOOD FRACTIONS AND MODIFIED IMMUNOLOGICAL PRODUCTS, CN CODE 30021091 : HAEMOGLOBIN, BLOOD GLOBULINS AND SERUM GLOBULINS.

ALSO CLASSIFIED IN ACCORDANCE WITH : HSEN NOTE (C) (2) TO HEADING 3002.

BTI Reference:
GB503331988.
Start date of validity:
.
End date of validity:
2016-12-31.

National keywords: ANTIBODIES IN SOLUTION

SOLIRIS IS A THERAPY SPECIFICALLY TESTED…

SOLIRIS IS A THERAPY SPECIFICALLY TESTED AND APPROVED FOR THE TREATMENT OF PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) AN ULTRA-RARE LIFE THREATENING BLOOD DISORDER.

SOLIRIS 300MG/30ML IS A FORMULATION OF ECULIZUMAB WHICH IS RECOMBINANT HUMANIZED MONOCLONAL LGG2/4;&#954 ANTIBODY PRODUCED BY MURINE MYELOMA CELL CULTURE AND PURIFIED BY STANDARD BIOPROCESS TECHNOLOGY.

ECULIZUMAB CONTAINS HUMAN CONSTANT REGIONS FROM HUMAN IMMUNOGLOBULIN G2 SEQUENCES AND HUMAN IMMUNOGLOBULIN G4 SEQUENCES AND MURINE COMPLEMENTARITY-DETERMINING REGIONS GRAFTED ONTO THE HUMAN FRAMEWORK LIGHT AND HEAVY CHAIN VARIABLE REGIONS.

ECULIZUMAB IS COMPOSED OF TWO 448 AMINO ACID HEAVY CHAINS AND TWO 214 AMINO ACID LIGHT CHAINS AND HAS A MOLECULAR WEIGHT OF APPROXIMATELY 148 KDA.

SOLIRIS 300 MG/30ML IS A STERILE COLOURLESS PRESERVATIVE-FREE SOLUTION FOR INTRAVENOUS INFUSION AND IS SUPPLIED IN 30ML SINGLE USE VIALS.

THE PRODUCT IS FORMULATED AT PH7 AND EACH VIAL CONTAINS 300 MG OF ECULIZUMAB 13.8 MG SODIUM PHOSPHATE MONOBASIC. 53.4 MG SODIUM PHOSPHATE DIBASIC 263.1 MG SODIUM CHLORIDE, 6.6 MG POLYSORBATE 80 (VEGETABLE ORIGIN) AND WATER FOR INJECTION.

THE DP AND FP ARE SUPPLIED IN VIALS, HOWEVER BDS IS SUPPLIED IN 100L BAGS . THE COMPOSITION OF THE PRODUCT IS THE SAME WHETHER BDS DP OR FP.

CAS NO. 219685-50-4.

Classification justification: CLASSIFICATION HAS BEEN DETERMINED IN ACCORDANCE WITH THE FOLLOWING :- GENERAL INTERPRETATIVE RULES (GIRs) GIR 1 HAS BEEN USED TO CLASSIFY THIS PRODUCT BY THE TERMS OF HEADING 3002 - HUMAN BLOOD, ANIMAL BLOOD PREPARED FOR THE THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC USES; ANTISERA AND OTHER BLOOD FRACTIONS AND MODIFIED IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; VACCINES, TOXINS,CULTURES OF MICRO-ORGANISMS (EXCLUDING YEASTS) AND SIMILAR PRODUCTS.

GIR 3B HAS BEEN USED AS THE ECULIZUMAB IS THE ESSENTIAL CHARACTER. GIR 5B HAS BEEN USED TO IDENTIFY THE TYPE OF PACKAGING.

GIR 6 HAS BEEN USED TO CLASSIFY THE GOODS TO SUBHEADING LEVEL 300210 - ANTISERA AND OTHER BLOOD FRACTIONS AND MODIFIED IMMUNOLOGICAL PRODUCTS, CN CODE 30021091 - HAEMOGLOBIN, BLOOD GLOBULINS AND SERUM GLOBULINS.

ALSO CLASSIFIED IN ACCORDANCE WITH: HSEN NOTE (C) (2) TO HEADING 3002.

BTI Reference:
GB503319972.
Start date of validity:
.
End date of validity:
2016-12-31.

National keywords: ANTIBODIES IN SOLUTION

TEST KIT CONSISTING OF BLOOD GROUPING REAGENTS…

TEST KIT CONSISTING OF BLOOD GROUPING REAGENTS AND 12 X 8 STRIPS OF MICROWELLS COATED WITH ANTI PLATELET ANTIBODIES

Classification justification: GENERAL INTERPRETATIVE RULES 1 & 6 TEXT TO CODES 3002 & 3002 10 91 00 HARMONISED SYSTEM EXPLANATORY NOTES TO HEADING 3002 REF: R00A1216 STATE LABORATORY ADVICE EUROPEAN COURT OF JUSTICE CASE C-191/91

BTI Reference:
IE13NT-14-1647-04.
Start date of validity:
.
End date of validity:
2016-12-31.

National keywords: DIAGNOSTIC REAGENTS ANTIBODIES MONOCLONAL

SOLIRIS IS A THERAPY SPECIFICALLY TESTED…

SOLIRIS IS A THERAPY SPECIFICALLY TESTED AND APPROVED FOR THE TREATMENT OF PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) AN ULTRA-RARE LIFE THREATENING BLOOD DISORDER.

SOLIRIS HAS BEEN APPROVED FOR THE TREATMENT OF PATIENTS WITH PNH IN NEARLY 50 COUNTRIES WORLDWIDE.

SOLIRIS 300MG/30ML IS A FORMULATION OF ECULIZUMAB WHICH IS RECOMBINANT HUMANIZED MONOCLONAL LGG2/4;&#954 ANTIBODY PRODUCED BY MURINE MYELOMA CELL CULTUREAND PURIFIED BY STANDARD BIOPROCESS TECHNOLOGY.

ECULIZUMAB CONTAINS HUMAN CONSTANT REGIONS FROM HUMAN IMMUNOGLOBULIN G2 SEQUENCES AND HUMAN IMMUNOGLOBULIN G4 SEQUENCES AND MURINE COMPLEMENTARITY DETERMINING REGIONS GRAFTED ONTO THE HUMAN FRAMEWORK LIGHT AND HEAVY CHAIN VARIABLE REGIONS.

ECULIZUMAB IS COMPOSED OF TWO 448 AMINO ACID HEAVY CHAINS AND TWO 214 AMINO ACID LIGHT CHAINS AND HAS A MOLECULAR WEIGHT OF APPROXIMATELY 148 KDA.

SOLIRIS 300 MG/30ML IS A STERILE COLOURLESS PRESERVATIVE-FREE SOLUTION FOR INTRAVENOUS INFUSION AND IS SUPPLIED IN 30ML SINGLE USE VIALS.

THE PRODUCT IS FORMULATED AT PH7 AND EACH VIAL CONTAINS 300 MG OF ECULIZUMAB 13.8 MG SODIUM PHOSPHATE MONOBASIC. 53.4 MG SODIUM PHOSPHATE DIBASIC 263.1 MG SODIUM CHLORIDE, 6.6 MG POLYSORBATE 80 (VEGETABLE ORIGIN) AND WATER FOR INJECTION.

THE DP AND FP ARE SUPPLIED IN VIALS, HOWEVER BDS IS SUPPLIED IN 100L BAGS . THE COMPOSITION OF THE PRODUCT IS THE SAME WHETHER BDS DP OR FP.

Classification justification: CLASSIFICATION HAS BEEN DETERMINED IN ACCORDANCE WITH THE FOLLOWING :- GENERAL INTERPRETATIVE RULES (GIRs) GIR 1 HAS BEEN USED TO CLASSIFY THIS PRODUCT BY THE TERMS OF HEADING 3002: HUMAN BLOOD, ANIMAL BLOOD PREPARED FOR THE THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC USES; ANTISERA AND OTHER BLOOD FRACTIONS AND MODIFIED IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; VACCINES, TOXINS,CULTURES OF MICRO-ORGANISMS (EXCLUDING YEASTS) AND SIMILAR PRODUCTS.

GIR 3B HAS BEEN USED AS THE ECULIZUMAB IS THE ESSENTIAL CHARACTER. GIR 5B HAS BEEN USED TO IDENTIFY THE TYPE OF PACKAGING - VIALS AND 100L BAGS.

GIR 6 HAS BEEN USED TO CLASSIFY THE GOODS TO SUBHEADING LEVEL 300210 : ANTISERA AND OTHER BLOOD FRACTIONS AND MODIFIED IMMUNOLOGICAL PRODUCTS, CN CODE 30021091 : HAEMOGLOBIN, BLOOD GLOBULINS AND SERUM GLOBULINS.

ALSO CLASSIFIED IN ACCORDANCE WITH : HSEN NOTE (C) (2) TO HEADING 3002.

BTI Reference:
GB502962459.
Start date of validity:
.
End date of validity:
2022-04-14.

National keywords: ANTIBODIES IN SOLUTION

SUPERCHEMIBLOCK HETEROPHILE BLOCKING AGENT,…

SUPERCHEMIBLOCK HETEROPHILE BLOCKING AGENT, IT IS HIGHLY PURIFIED MOUSE IMMUNOGLOBULINS WITH PROPRIETARY AUGMENTING REAGENTS, A NON-STERILE LIQUID.

Classification justification: GENERAL INTERPRETATIVE RULES 1 & 6 TEXT TO CODES 3002 AND 3002 10 91 00 HARMONISED SYSTEM EXPLANATORY NOTES TO HEADING 3002 STATE LAB ADVICE

BTI Reference:
IE13NT-14-1555-04.
Start date of validity:
.
End date of validity:
2019-09-04.

National keywords: REAGENTS

RABBIT GAMMA GLOBULIN WHICH IS PURIFIED FROM…

RABBIT GAMMA GLOBULIN WHICH IS PURIFIED FROM RABBIT PLASMA OR SERUM SOURCE: RABBIT BLOOD FORM: LYOPHILIZED

Classification justification: GENERAL INTERPRETATIVE RULES 1 & 6 TEXT TO CODES 3002 AND 3002 10 91 00 HARMONISED SYSTEM EXPLANATORY NOTES TO HEADING 3002

BTI Reference:
IE13NT-14-1555-03.
Start date of validity:
.
End date of validity:
2019-09-04.

National keywords: SERUM GLOBULINS

IMMUNOASSAY REAGENT KIT. USED "IN VITRO"

IMMUNOASSAY REAGENT KIT. USED "IN VITRO"

Classification justification: CLASSIFICATION IS DETERMINED BY GENERAL INTERPRETATIVE RULES 1 AND 6 FOR THE INTERPRETATION OF THE COMBINED NOMENCLATURE; BY THE TEXT OF CODES 3002 AND 3002 10 91; THE HARMONISED SYSTEM EXPLANATORY NOTES TO HEADING 3002.

BTI Reference:
IE12NT-14-889-01.
Start date of validity:
.
End date of validity:
2018-11-04.

National keywords: IN VITRO AS LIQUID ANTIBODIES REAGENTS HORMONES

MOUSE MONOCLONAL ANTIBODY POWDER SOLUTION…

MOUSE MONOCLONAL ANTIBODY POWDER SOLUTION FOR INFUSION PACK: 1X10 THERAPUTIC AREA: MALIGNANT DISEASE AND IMMUNOSUPPRESSION.

Classification justification: CLASSIFICATION HAS BEEN DETERMINED IN ACCORDANCE WITH THE FOLLOWING:- GENERAL INTERPRETATIVE RULES (GIR)S:- GIR 1 HAS BEEN USED TO CLASSIFY THIS PRODUCT BY THE TERMS OF HEADING 3002 HUMAN BLOOD; ANIMAL BLOOD PREPARED FOR THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC USES; ANTISERA AND OTHER BLOOD FRACTIONS AND MODIFIED IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; VACCINES, TOXINS, CULTURES OF MICRO-ORGANISMS (EXCLUDING YEASTS) AND SIMILAR PRODUCTS.

GIR 6 HAS BEEN USED TO CLASSIFY THE GOODS TO SUBHEADING LEVEL 300210 ANTISERA AND OTHER BLOOD FRACTIONS AND MODIFIED IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES.

CN CODE 30021099 OTHER THAN OF HUMAN ORIGIN. ALSO CLASSIFIED IN ACCORDANCE WITH:- CHAPTER 30 NOTE 2.

HSEN NOTE ( C ) (2) (A) TO HEADING 3002. HSEN EXCLUSION (B) TO HEADING 3004. CNEN TO CODES 30021095 AND 30021099.

BTI Reference:
GB501067887.
Start date of validity:
.
End date of validity:
2012-12-31.

National keywords: AS POWDER ANTIBODIES MONOCLONAL

GOAT POLYCLONAL SECONDARY ANTIBODY TO RABBIT…

GOAT POLYCLONAL SECONDARY ANTIBODY TO RABBIT IGG CONJUGATED TO FITC (A FLUROPHORE) IN A BUFFER CONTAINING 0.2% BSA, PBS PRESERVATIVE 0.09% SODIUM AZIDE.

THE ANTIBODY IS MADE BY HARVESTING THE ANTISERUM FROM THE BLOOD OF A GOAT. THE ANTIBODY IS THEN PURIFIED BY AFFINITY CHROMATOGRAPHY AND THEN CONJUGATED TO FITC (A FLUROPHORE), THE PRODUCT IS PRESENTED IN A 2 ML SCREW TOP AMBER TUBE FOR USE IN VITRO RESEARCH.

Classification justification: CLASSIFICATION HAS BEEN DETERMINED IN ACCORDANCE WITH THE FOLLOWING:- GENERAL INTERPRETATIVE RULES (GIR)S GIR 1 HAS BEEN USED TO CLASSIFY THIS PRODUCT BY THE TERMS OF HEADING 3002 - HUMAN BLOOD; ANIMAL BLOOD PREPARED FOR THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC USES; ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; VACCINES, TOXINS, CULTURES OF MICRO-ORGANISMS(EXCLUDING YEASTS) AND SIMILAR PRODUCTS.

GIR 6 HAS BEEN USED TO CLASSIFY THE GOODS TO SUBHEADING LEVEL 300210 - ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES CN CODE 30021099 - OTHER THAN ELSEWHERE SPECIFIED, AND NOT OF HUMAN ORIGIN ALSO CLASSIFIED IN ACCORDANCE WITH :- CHAPTER 30, GENERAL CHAPTER NOTE 2 HSEN NOTE (C) (2) (C) TO HEADING 3002

BTI Reference:
GB121198885.
Start date of validity:
.
End date of validity:
2018-01-10.

National keywords: IN VITRO ANTIBODIES FOR SCIENTIFIC RESEARCH

OSTEOPONTIN MOUSE ELISA KIT. THIS KIT IS…

OSTEOPONTIN MOUSE ELISA KIT. THIS KIT IS AN IN VITRO ENZYME-LINKED IMMUNOSORBENT ASSAY FOR THE QUANTITATIVE MEASUREMENT OF MOUSE OSTEOPONTIN IN SERUM, PLASMA AND CELL CULTURE SUPEMATANTS.

THE KIT CONTAINS THE FOLLOWING ITEMS: 96 WELL ELISA PLATE COATED WITH AN ANTI OSTEOPONTIN CAPTURE ANTIBODY, WASH BUFFER CONCENTRATE, STANDARDS:RECOMBINANT MOUSE OSTEOPONTIN, ASSAY BUFFERS, DETECTION ANTIBODY - BIOTINYLATED, HRP STREPTAVIDIN CONCENTRATE, TMB ONE STEP SUBSTRATE REAGENT, STOP SOLUTION OF SULPHURIC ACID.

THE KIT IS PRESENTED IN A BOX CONTAINING 10 BOTTLES OR TUBES TOGETHER WITH INSTRUCTION BOOKLET.

Classification justification: CLASSIFICATION HAS BEEN DETERMINED IN ACCORDANCE WITH THE FOLLOWING:- GENERAL INTERPRETATIVE RULES (GIR)S GIR 1 HAS BEEN USED TO CLASSIFY THIS PRODUCT BY THE TERMS OF HEADING 3002 - HUMAN BLOOD; ANIMAL BLOOD PREPARED FOR THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC USES; ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; VACCINES, TOXINS, CULTURES OF MICRO-ORGANISMS(EXCLUDING YEASTS) AND SIMILAR PRODUCTS.

GIR 3B HAS BEEN USED AS THE DETECTION AND CAPTURE ANTIBODY OF THE KIT IS CONSIDERED TO BE THE ESSENTIAL CHARACTER.

GIR 6 HAS BEEN USED TO CLASSIFY THE GOODS TO SUBHEADING LEVEL 300210 - ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES CN CODE 30021099 - OTHER THAN ELSEWHERE SPECIFIED ALSO CLASSIFIED IN ACCORDANCE WITH :- CHAPTER 30, GENERAL CHAPTER NOTE 2 HSEN NOTE (E) TO HEADING 3002

BTI Reference:
GB121203246.
Start date of validity:
.
End date of validity:
2018-01-10.

National keywords: IN VITRO FOR DIAGNOSTIC USE ANTIBODIES INSTRUCTION BOOKLETS FOR SCIENTIFIC RESEARCH