GeM | Bidding

Category	Specification	Bid Requirement (Allowed Values)
GENERAL	Product Description	Pregnancy Rapid Test Kit
PRODUCT INFORMATION	Detection Type	Qualitative
Testing Principle	Single Step, self performing sandwiched immunoassay using colloidal gold and anti hCG antibodies in lateral flow immunochromatography format
Specimen required for testing	Urine
Ability to Evaluate Negative or Positive test result	Yes
Sensitivity	≥25 milli I.U/ ml of urine
Built-in control for confirmation that the test has been performed correctly	Yes
KIT CONTENTS	Main item in test kit for performing the test	Card/Cassette
PACKAGING	Each test kit should be indivdually packed in a moisture proof pouches	Yes
CERTIFICATIONS & REPORTS	Manufacturing unit certification	ISO:13485 (Latest)
Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date	Yes
Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement	Yes
SHELF LIFE	Shelf life in months from the date of manufacture	24, 36 Or higher
Minimum shelf life of the product at the time of delivery to the consignee	3/4th of Total Shelf Life
ADVANCE SAMPLE	Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding	Yes

Category

Specification

Bid Requirement (Allowed Values)

GENERAL

Product Description

Pregnancy Rapid Test Kit

PRODUCT INFORMATION

Detection Type

Qualitative

Testing Principle

Single Step, self performing sandwiched immunoassay using colloidal gold and anti hCG antibodies in lateral flow immunochromatography format

Specimen required for testing

Urine

Ability to Evaluate Negative or Positive test result

Yes

Sensitivity

≥25 milli I.U/ ml of urine

Built-in control for confirmation that the test has been performed correctly

Yes

KIT CONTENTS

Main item in test kit for performing the test

Card/Cassette

PACKAGING

Each test kit should be indivdually packed in a moisture proof pouches

Yes

CERTIFICATIONS & REPORTS

Manufacturing unit certification

ISO:13485 (Latest)

Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date

Yes

Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement

Yes

SHELF LIFE

Shelf life in months from the date of manufacture

24, 36 Or higher

Minimum shelf life of the product at the time of delivery to the consignee

3/4th of Total Shelf Life

ADVANCE SAMPLE

Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding

Yes