GeM

AOC

Goods

Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits

PRODUCT

Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits Average Turnover (Last 3 Years) 3 Lakh (s)

Health And Family Welfare Department Delhi

Shahdara, Delhi

Amount: Refer DocsCloses: 2 Sept 2019Closed

Timeline

Published23 Aug 2019
Closed2 Sept 2019
Awarded6 Sept 2019

Bids

7 Bids6 Sept 2019

#	Company	Offered Item	Amount	Rank	Status
1	Diagnocure INDIA L1₹4.7 LQualified Make: Diagnocure India Model: Diagno HBsAg CHAMBAGHAT SOLAN HIMACHAL PRADESH 173213 \| SOLAN \| HIMACHAL PRADESH \| 173213	Make: Diagnocure India Model: Diagno HBsAg	₹4.7 L	L1	Qualified MSE, Category: General
2	VOXTUR BIO LIMITED L2₹5.1 L+₹41,004 (8.67%)Qualified Make: VOXTUR Model: 10RT10950 BHIWANDI ROAD PALGHAR MAHARASHTRA 401208 \| PALGHAR \| MAHARASHTRA \| 401208	Make: VOXTUR Model: 10RT10950	₹5.1 L+₹41,004 (8.67%)	L2	Qualified MSE, Category: General
3	Pioneer Associates L3₹5.2 L+₹49,848 (10.5%)Qualified Make: Med Source Ozone Model: IS IT HBsAg 204 IIND FLOOR VARDHAMAN PLAZA O P BLOCK DILSHAD GARDEN NORTH EAST DELHI	Make: Med Source Ozone Model: IS IT HBsAg	₹5.2 L+₹49,848 (10.5%)	L3	Qualified
4	EMBEE DIAGNOSTICS PVT LTD L4₹5.4 L+₹65,928 (13.9%)Qualified Make: VOXTUR Model: VOXTURE, Model - Voxpress HbsAg 1864 65 HAVELI JUGAL KISHORE CHANDNI CHOWK DELHI CENTRAL DELHI DELHI 110006 \| NORTH DELHI \| DELHI \| 110006	Make: VOXTUR Model: VOXTURE, Model - Voxpress HbsAg	₹5.4 L+₹65,928 (13.9%)	L4	Qualified
5	KOTHARI DISTRIBUTORS L5₹5.4 L+₹69,144 (14.6%)Qualified Make: MAXLINE Model: Maxline HBsAg 13 5 2ND FLOOR 3RD CROSS GANDHINAGAR BENGALURU URBAN KARNATAKA 560009 \| BENGALURU URBAN \| KARNATAKA \| 560009	Make: MAXLINE Model: Maxline HBsAg	₹5.4 L+₹69,144 (14.6%)	L5	Qualified

Tender Value

Refer Docs

EMD Value

Exempted

Closing Date

2 Sept 2019, 3:00 pmClosed

Work Description

Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits Average Turnover (Last 3 Years) 3 Lakh (s)

Tender Information

Tender ID

1364748

Reference Number

GEM/2019/B/329619

Tender Type

GeM Contract

Product Category

Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits

Form of Contract

GeM Contract

Period of Work

15 days

Location

Delhi; Shahdara

Bid Type

PRODUCT

Source Website

Subscribe to view

Awarded Items

GEMC-511687772337352

Awarded to Diagnocure INDIA

₹4.7 L

Products

Product	Brand / Model	HSN	Quantity	Unit Price	Amount
Diagno HBsAg	Diagno HBsAg	-	80,400 pieces	₹5.88	472,752

Documents Required

20 documents required · 20 mandatory

RequiredExperience with Government

RequiredAnnual Turnover

RequiredOEM Authorization Certificate

RequiredOEM Annual Turnover Bid to RA enabled No Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits ( 80400 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) GENERAL FEATURES Product Description Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits * Clinical Purpose To provide diagnosis of Hepatitis B Virus infection * 1/6 PRODUCT INFORMATION Detects Hepatitis B Surface Antigen (HBsAg) * Should be solid phase particle coated with monoclonal antibodies to HBsAg Yes * Test Should be able to detect all 11 subtype of HBsAg Yes * Test can be performed on Serum

RequiredPlasma Serum

RequiredPlasma Type of Test Qualitative Qualitative Testing Principle Lateral flow chromatographic immunoassay Lateral flow chromatographic immunoassay Result Time (min) 5-10 * Ability to Evaluate Negative or Positive test result Yes * Sensitivity (%) 95 * Specificity (%) 95 * Contains an internal control line/dot for the confirmation that the test has been performed correctly Yes * Storage temperature 2°C to 30°C * The supplier should ensure maintenance of recommended temperature during storage and transportation of Kit Yes * The kit should comply with all provisions of Drugs and cosmentics Act

Required1940 and applicable rules there under Yes * KIT CONTENTS Main items in test kit for performing the test Card Card Sample Dropper Provided with each card/strip Yes * Dessicant to absorb moisture so that the Card/Strip do not get spoiled provided with Yes * 2/6 each card Sample Diluent/Assay Buffer Provided Yes * Packaging insert in English detailing the principle

Requiredcomponents

Requiredmethodologies

Requiredvalidity criteria

Requiredperformance c haracteristics

Requiredbio- safety

Requiredlimitations of assay

Requiredstorage condition

Requiredmanufacturing and expiry dates and methods of disposal Provided with each kit Yes * Reactive and non reactive controls provided with each kit in adequate volume (minimum 10% of pack size) Yes Yes

RequiredNo Individually packed sterile disposable lancets and disposable alcohol swabs provided with each test kit No Yes

RequiredNo Other accessories and spares provided if any for standard pack in the kit - * PACKAGING Pack Size 50 Tests Pack * The packing and labelling should be as per Drugs and Cosmetics Act

Required1940 and applicable rules there under Yes * Each card (cassette) should have space for patients particulars and date of the test Yes * The test kit should be packed in such a way that there is proivision to conduct single test at a time Yes * Each test kit should be indivdually packed in a hermetically sealed and non-permeable Yes * 3/6 pouch CERTIFICATIONS & REPORTS The kit should have approval of the statutory authority in its country of origin Yes * The Kit should be registered and licensed in India by DCGI in case of imported kits (Proof of the same to be submitted to buyer on demand) - * Indigenous manufacturers should be licensed by the competent authority defined under Drugs and Cosmetics act 1940 - * Availability of valid drug license from competent authority defined under Drugs and Cosmetics Act

Required1940 (Proof of the same to be submitted to buyer on demand) - * Drug License Number - * Drug License Date - * Manufacturer certifications (Proof of the same to be submitted to the buyer on demand) - * GMP/WHO GMP Certification Number - * GMP/WHO GMP Certification Date - * ISO 13485 Certified Manufacturer (Proof of the same to be submitted to buyer on demand) Yes * Product Certifications (Proof of the same to be submitted to buyer on demand) EU-CE (IVD) * Four digit number of notified body If product is EU-CE certified - * 4/6 Certificatiion Number - * Certificatiion Date - * Certification Issuing Authority - * Availability of Test report from Central GOVT/NABL/ILAC accredited Lab to prove the conformity to the declared specification( proof of the same to be submitted to the buyer on demand) Yes * Availability of Performance Evaluation Report (Proof of the same to be submitted to the buyer on demand) Yes * Performance Evaluation Report issuing body National Insitute of Biological Sciences * Name of the Performance Evaluation Report issuing body if other than specified institute - * SHELF LIFE Shelf Life (in months) 24 24 The product should not have passed more than 1/6 of the total shelf life at the time of dispatch to the consignee Yes * * Bold specifications are the golden parameters. * Bidders may note that In respect of non-golden Parameters

Requiredthe specifications 'Values' chosen by Buyer will generally be preferred over 'Bid requirement ( allowed Values) by the Buyer.

Eligibility Criteria

OEM Turnover

₹22 L

Purchase Preferences

MSE EMD ExemptionStartup Exemption

Items & Quantities

Item	Delivery Location	Qty	Delivery
Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits Average Turnover (Last 3 Years) 3 Lakh (s)	-	80,400	-

Total: 80,400

Fee & Financial Details

EMD Fee Amount

Exempted

Important Dates

Last Activity

6 Sept 2019

Published

23 Aug 2019

Stage Documents

Award of Contract

contract_GEMC-511687772337352.pdf

GEM_CONTRACT • 0.01 MB

Documents

Tap a document below to read it instantly. You can also download everything as a ZIP if you prefer.

Tender Documents

bid_1364748.pdf

GEM_BID

Work Item Documents

termsCondition.pdf

OTHER

2657c7ca70287299b5181580fdb5a7ab.pdf

OTHER

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Download all tender documents and submit your bid

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Company

Diagnocure INDIA

L1₹4.7 LQualified

Make: Diagnocure India Model: Diagno HBsAg

CHAMBAGHAT SOLAN HIMACHAL PRADESH 173213 | SOLAN | HIMACHAL PRADESH | 173213

VOXTUR BIO LIMITED

L2₹5.1 L+₹41,004 (8.67%)Qualified

Make: VOXTUR Model: 10RT10950

BHIWANDI ROAD PALGHAR MAHARASHTRA 401208 | PALGHAR | MAHARASHTRA | 401208

Pioneer Associates

L3₹5.2 L+₹49,848 (10.5%)Qualified

Make: Med Source Ozone Model: IS IT HBsAg

204 IIND FLOOR VARDHAMAN PLAZA O P BLOCK DILSHAD GARDEN NORTH EAST DELHI

EMBEE DIAGNOSTICS PVT LTD

L4₹5.4 L+₹65,928 (13.9%)Qualified

Make: VOXTUR Model: VOXTURE, Model - Voxpress HbsAg

1864 65 HAVELI JUGAL KISHORE CHANDNI CHOWK DELHI CENTRAL DELHI DELHI 110006 | NORTH DELHI | DELHI | 110006

KOTHARI DISTRIBUTORS

L5₹5.4 L+₹69,144 (14.6%)Qualified

Make: MAXLINE Model: Maxline HBsAg

13 5 2ND FLOOR 3RD CROSS GANDHINAGAR BENGALURU URBAN KARNATAKA 560009 | BENGALURU URBAN | KARNATAKA | 560009

Product

Brand / Model

HSN

Quantity

Unit Price

Amount

Diagno HBsAg

80,400 pieces

₹5.88

472,752

Item

Delivery Location

Qty

Delivery

Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits Average Turnover (Last 3 Years) 3 Lakh (s)

80,400