National Institutes for Food and Drug Control 360039-202001 C-reactive Protein Standard Product Leaflet

This leaflet provides usage instructions, specifications, packaging, storage, and safety information for the CRP national standard reference material (batch…


National Institutes for Food and Drug Control 360039-202001 C-reactive Protein Standard Product Leaflet - cover page
Brand
National Institutes for Food and Drug Control
Document type
Product Leaflet
Language
Chinese
Pages
2
File format
PDF
File size
133 KB
Published
03 October, 2026
Updated
03 October, 2026
MD5 checksum
604BF457A6D2F98A6DF1C7E1AACBD006

About this manual

The C‑reactive protein (CRP) national standard is a lyophilized reference material produced by the National Institutes for Food and Drug Control. It is intended for accuracy evaluation of CRP assay kits, especially those based on immunoturbidimetry and chemiluminescence methods.

The standard should be reconstituted with 1 mL deionized water, mixed thoroughly, and further diluted with validated diluent as needed. It must be stored at ≤ ‑20 °C, protected from repeated freeze‑thaw cycles, and handled with biosafety precautions because it contains human‑derived material. No fixed expiration date is assigned; the material remains valid until a formal discontinuation notice is issued. This manual is written in Chinese.

What's inside

  • Category
  • Batch number
  • Physical appearance
  • Purpose
  • Composition and specifications
  • Characteristic values
  • Usage method and requirements
  • Packaging
  • Storage
  • Precautions

Specifications

Physical formWhite lyophilized powder
Batch number360039-202001
Content per ampoule36.82 ± 3.43 µg C‑reactive protein
Packaging2 mL glass ampoule
Storage temperature≤ ‑20 °C

Frequently asked questions

How should the CRP standard be reconstituted?

Add 1 mL deionized water to the ampoule, dissolve the contents completely, and mix thoroughly before use.

What relative bias is acceptable for assay accuracy?

The measured value should be within ±15.0 % relative deviation from the target value.

What are the storage requirements for the standard?

Store the material at –20 °C or lower and avoid repeated freeze‑thaw cycles.

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