Anti-D Blood Grouping Sera

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Description

GENERAL FEATURES

Type of Blood Grouping Sera/Reagent Anti-D Grouping Sera (IgM + IgG)
Clinical Purpose For Rh Blood Typing
Antibody Type Monoclonal
Suitable for Tube Method,Slide Method,Microplate method
Anti-D reagent should be capable of detecting all weak and partial D Yes
Titre should be ≥ 1:32 with D positive cell in immediate spin and ≥ 1:128 after 30-40 minutes incubation Yes
Ready to use reagent containing antibodies specific to the ‘D’ antigen on RBC Yes
Dropper Provided Yes
Reagent should have avidity less than 10 seconds Yes
Should not hemolyze cells or produce rouleux Yes
Storage Temperature 2°C to 8°C
It should give easily observable agglutination reaction with antigen positive cells and clear absence of agglutination reaction in antigen negative cells Yes
Reagent should meet the standards approved by USFDA/CDSCO/NIB for blood bank reagents with respect to appearance, color, sensitivity, specificity, avidity, affinity and titer strength Yes
Reagent should meet the standards mentioned in the technical manual for blood banks approved by the MOHFW, GOI Yes
All Provisions of Drugs and Cosmetics Act, 1940 as amended till Date and rules made there under will always be applicable Yes

CERTIFICATIONS & REPORTS

Availability of valid drug license issued from competent authority defined under Drugs and Cosmetics Act, 1940 (copy of the same to be submitted to buyer on demand) For Manufacture,For Sale
Drug License Number N (1094)/15/W
Drug License Date 05.11.2015
Manufacturer certifications (copy of the same to be submitted to the buyer on demand) ISO 13485,GMP,WHO GMP
Certification Number 00093-0
Certification Date 23.12.2008
Product Certification (copy of the same to be submitted to buyer on demand if certification is available) EU-CE (IVD)
Four digit number of notified body If product is EU-CE certified 1947
Product Certification Number 236145
Product Certification Date 20.04.2016
Certificate issuing Authority DRUG CONTROLLER
Availability of Test report from Central GOVT/NABL/ILAC accredited Lab to prove the conformity to the declared specifications(copy of the same to be submitted to the buyer on demand) Yes
Evaluated and approved by National Institute of Biologicals (NIB) (copy of the same to be submitted to the buyer on demand) Yes

PACKAGING AND LABELING

Packing Type Vial
Pack size 10 ml
Number of Vials in one pack 1
Packaging insert provided Yes
Each vial should be labeled as per provisions given for labeling in Drugs and cosmetics act 1940 and rules made there under Yes

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