Anti-A Blood Grouping Sera

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Description

GENERAL FEATURES

Type of Blood Grouping Sera/Reagent Anti-A Grouping Sera IgM
Clinical Purpose For ABO Blood Grouping
Antibody Type Monoclonal
Suitable for Slide Method,Tube Method
Ready to use reagent containing antibodies specific to the ‘A’ antigen on RBC Yes
Titre ≥ 1:256 with A cell and negative with B Cell
Dropper Provided Yes
Reagent should have avidity less than 4 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

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

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 MH/101500
Drug License Date 12/10/2015
Manufacturer certifications (copy of the same to be submitted to the buyer on demand) ISO 13485
Certification Number ISO 13485 2016
Certification Date 10/08/2017
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 1097
Product Certification Number MH/101500
Product Certification Date 12/10/2015
Certificate issuing Authority FDA
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

SHELF LIFE

Shelf Life from the date of manufacture (in months) 24
The product should have atleast 3/4 of the total shelf life at the time of dispatch to the consignee Yes

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