Published advance ruling · Classification
NCS/ARS/CL/10179
- Advance ruling number
- NCS/ARS/CL/10179
- System reference
- 10179
- Date of issue
- 2025-01-17
- Category
- Classification
- Name of applicant
- Withheld — applicant details are not published
- Product
- BD BACTEC™ Plus Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
- Product specification / details
You have requested for the tariff classification of BD BACTEC™ Plus Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial of size 30ml. According to your supporting documents the product is a medium used in a qualitative procedure for the anaerobic culture and recovery of microorganisms (bacteria) from blood. Its principal use is with the BD BACTEC fluorescent series instruments. The prepared culture vials are for in vitro diagnostic use.
A culture vial is a small glass bottle with lid, often filled with a liquid in which bacteria grow. This liquid, a nutrient broth solution allows a liquid or gel to provide all the nutrients needed for bacteria to grow successfully. These must include carbohydrates for energy, nitrogen for protein synthesis, plus other minerals. (Bacterial growth in cultures - Treating, curing and preventing disease - Edexcel - GCSE Biology (Single Science) Revision - Edexcel - BBC Bitesize).
Procedure for Use
The sample to be tested is inoculated into one or more vials which are inserted into the BD BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms.
The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Resins have been incorporated into BD BACTEC culture media to enhance recovery of organisms without a need for special processing.Composition of reagents
REAGENTS The BD BACTEC culture vials contain the following reactive ingredients prior to processing:
- Processed Water - 3oml w/v
- Soybean-Casein Digest Broth -3.0%
- Yeast Extract - 0.4%
- Animal Tissue Digest - 0.05%
- Amino Acids - 0.25%
- Sugar - 0.25%
- Sodium Citrate - 0.02%
- Sodium Polyanetholsulfonate (SPS) - 0.05%
- Vitamins - 0.0006%
- Antioxidants/Reductants - 0.16%
- Nonionic Adsorbing Resin - 13.4%
- Cationic Exchange Resin - 0.9
The manufacturer has stated that the composition is adjustable to meet specific performance requirements.
Tariff ClassificationThis product is excluded from tariff classification under tariff heading 3006 because it will not be administered directly to the patient (see legal note 4d to chapter 30).
Accordingly, BD BACTEC™ Plus Anaerobic/F Culture Vials Soybean-Casein Digest Broth is effectively classified in tariff heading 3822 - Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, whether or not put up in the form of kits; 3822 19 00 00 with 0% Duty and 0% VAT in the ECOWAS CET 2022 - 2027.
Legal Framework
GIR 1 - Terms of the Heading
GIR 6 - Terms of the subheading
- Tariff classification / rules of origin
- 3822 19 00 00
- Legal framework (GIRs) applied / PFTA RoO criteria (ETLS, AfCFTA)
- Not stated