Antisera-based diagnostic product classifies under Chapter 30 when derived from animal blood and used for laboratory testing.

Hepa Card/Strip used for Hepatitis B detection was held classifiable under Chapter Heading 3002.00, because it was manufactured from goat blood through an antigen-antibody process and functioned as an antisera-based diagnostic product. Chapter Heading 3822.00 covers diagnostic reagents but excludes goods falling within Chapter 30, and the product's use in laboratory diagnosis did not alter its essential character as a prepared blood product. The absence of any label or literature reference to goat-blood origin was immaterial since the raw materials and manufacturing process were undisputed. The earlier classification approach for purified antisera used in in-vitro diagnostic testing was followed.

---

---

Issues: Whether Hepa Card/Strip used for detection of Hepatitis B in serum or plasma was classifiable under Chapter Heading 3822.00 as diagnostic or laboratory reagents, or under Chapter Heading 3002.00 as prepared animal blood and similar products.

Analysis: The product was manufactured from goat blood through an antigen and antibody process, and was used only for diagnostic purposes. Chapter Heading 3822.00 covers diagnostic or laboratory reagents, but excludes goods of Chapter 30, while Chapter Heading 3002.00 covers antisera and similar products. The fact that the product was not described in labels or literature as goat-blood derived was held to be immaterial because the raw materials and manufacturing process were undisputed. The reasoning adopted in the earlier decision on pregnancy test kits, where purified antisera from goat's blood used for in-vitro diagnostic testing was classified under Chapter 30, was applied.

Conclusion: Hepa Card/Strip was correctly classifiable under Chapter Heading 3002.00, and the departmental challenge to the assessee's classification failed.

Ratio Decidendi: A diagnostic product manufactured from animal blood-derived antisera remains classifiable under Chapter 30 when it is a prepared blood product and not merely a reagent of Chapter 38.

---