This standard specifies the general requirements for quality inspection of fibrinogen detection reagents (kits), including terms and definitions, requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage. This standard applies to Clauss method fibrinogen detection reagent (box) products for routine testing in clinical laboratories, including freeze-dried products and liquid reagent products. This standard does not apply to fibrinogen detection reagents (boxes) determined by physical and chemical methods and immunological methods.