Welcome to Beijing Beat IVD MD Technology!  

Add to Favorites | Setup as front page  | 中文 | EN

 
Tel:010-57253929
Home About us Services News Success cases Regulations Exhibitions Contacts US

current location: Home > Regulations > Product Inspection Guide of Clinical Laboratory Reagents

    Regulations

Contact: 010-57253929
18601253261
Website: www.bestivdmd.com
Online QQ:
 
 

Regulations

Product Inspection Guide of Clinical Laboratory Reagents

source:This site   release time: 2018-05-24 11:30:00   Browsing:364次  Font size: [大] [中] [小]
1) The quantities of batch should meet the standard 3) Enough empty reagent bottles and reference samples for accurate experiment are needed if there are other package
1.        What are the requirements for testing samples of the biochemical kit?
    1)        The quantities of batch should meet the standard.
    2)        The package of the kit is Hitachi 7180/7170/ package for the best.
    3)        Enough empty reagent bottles and reference samples for accurate experiment are needed if there are other packages.
   4)        High-value samples for linear test.
   5)        Quality control samples.
   6)        Other special items according to standards.
2.        What are the requirements for testing samples of the test strip for dry chemical urine analysis?
  1)        Four batches of urine test strips (three batches within the validity period, and  one batch closed to the validity. The minimum amount is 600 strips for each batch).
  2)        Preparation methods of concentration gradient solution for each item.
  3)        Substances with clear white blood cell count.
  4)        Instrument calibration bars.
  5)        Operation manual.
  6)        Applicable instruments and instructions.
3.        What are the requirements for testing samples of enzyme-linked immunosorbent assay (ELISA)?
  1)        You should provide three batches of kits. If the stability test requires the kit  over the validity period, additional kits should be submitted.
  2)        Auxiliary samples for test, such as sensitivity reference samples, negative reference samples, repetitive reference samples etc., should be provided at the same time. The corresponding proof of serum is needed (source, judgment method, batch, validity period, manufacturer etc.).
  3)        Labels of Chinese products should be provided while submitting samples, and must be consistent with the standards.
  4)        Chinese instructions should be provided while submitting samples.
4.        What are the requirements for testing samples of automatic biochemical analyzer?
  1)        Kits of ALT, BUN and TP, quality controls and calibrators are needed.
  2)        Standard solutions of potassium dichromate with absorbance 0.5 and 1.0 (purchased from National Institute of Metrology).
  3)        Necessary supplies that ensure the instrument can operate regularly.
5.        What are the requirements for testing samples of semi-automatic biochemical analyzer?
  1)        Kits of ALT, BUN and TP, quality controls and calibrators are needed.
  2)        Necessary supplies that ensure the instrument can operate regularly.
6.        What are the requirements for testing samples of electrolyte analyzer?
  1)        The serum matrix has constant value data measuring reference material (purchased from National Institute of Metrology).
  2)        Necessary supplies that ensure the instrument can operate regularly.
7.        What are the requirements for testing samples of test strip of blood glucose?
  1)        Blood glucose test strip to be tested: 4 batches of blood glucose strips. The main testing batch: 1,300 blood glucose test stripes within the validity period foe one batch; the testing between different batches: 50 blood glucose test stripes within the validity period for two batches respectively; the stability testing batch: 1,300 blood glucose test stripes the validity period.
  2)        Blood glucose meter matched with blood glucose test strip: 2 sets. Quality controls matched with blood glucose meter: Each level of the quality control within the validity period is 1 bottle.
  3)        Reference analyzer: automatic glucose/lactate analyzer (product model: YSL2300PLUS) and automatic biochemical analyzer (product model: Hitachi 7180, 7060c)can be provided by Our institute.
  4)        If the reference analyzer is not provided by our institute, the enterprise need to support auxiliary instrument, such as reference analyzer, supporting reagents, standard samples etc.
  5)        Blood: fresh human blood 30ml (the blood of the same person or the blood of the same blood type is needed  if there is a recovery experiment).
8.        What are the requirements for testing samples of the calibrator for blood cell analyzer?
  1)        You should provide at least two batches of calibrator for blood cell analyzer. At least 40 bottles is in the validity period (each bottle should be able to test 11 times). At least 5 bottles is over the validity period.
  2)        Clibrator, related reagents and sample cups being applicable for the blood analyzer (samples including the quality controls, diluted solution, hemolytic agent, wash buffer etc. using by the blood analyzer to be tested, all should be in the validity period).
  3)        HBsAg testing kit, HIV-1/HIV-2 antibody testing kit and HCV antibody testing kit.
  4)        Fresh blood assigned by reference method (at least above 2ml).
9.        What are the requirements for testing samples of quality controls for hematology analyzer?
  1)        You should provide at least two batches of quality control for blood cell analyzer. At least 40 bottles are in the validity period (each bottle should be able to test 11 times). At least 5 bottles is over the validity period.
  2)        Quality control, related reagents and sample cups applicated for the blood analyzer(samples including the quality calibrators, diluted solution, hemolytic agent, wash buffer etc. using by the blood analyzer to be tested, all should be in the validity period).
  3)        HBsAg testing kit, HIV-1/HIV-2 antibody testing kit and HCV antibody testing kit.
(From Beijing Institute Of Medical Device Testing)
 

Related Links

Home | Success cases | Online message | Link | Contacts US | Privacy Policy

Beijing Best IVD MD Technology Co., Ltd. www.bestivdmd.com
Addr: Room 310B, 310,310A,311,218,No.29 Building.No.61 Fuxing Road, Beijing, (100036) P.R.China, tel:010-57253929 18601253261 email:bestivdmd@bestivdmd.com
Copyright © 2007-2018 , All Rights Reserve Website Construction: soupu.net Website Management