Dengue ELISA Test Kit,Dengue ELISA Test Kit,Dengue ELISA Test Kit
Employees State Insurance Corporation
Posted:
21 May 2025
Closed:
31 May 2025
GEM
GEM
Employees State Insurance Corporation Dengue ELISA Kit Tender India 2026 MDR 2017 Compliant
Bid Publish Date
30-Jun-2026, 4:05 pm
Bid End Date
10-Jul-2026, 5:00 pm
Progress
Issue30-Jun-2026, 4:05 pm
AwardPending
Quantity
2112
Category
Dengue ELISA Test Kit
Bid Type
Two Packet Bid
Key Highlights
- • Regulatory compliance: MDR 2017 compliance for dengue ELISA kits
- • License requirement: valid medical device license under the Drugs and Cosmetic Act 1940
- • Serotype coverage: kit must detect DEN-1, DEN-2, DEN-3, DEN-4
- • Quantity flexibility: +/-25% order variation during and after contract award
- • Delivery timeline: extended delivery period calculation with minimum 30 days
- • Documentation: mandatory single PDF with product inserts (ATC)
Categories
2
Tender Overview
Organization: Employees State Insurance Corporation. Product: Dengue ELISA Test Kit capable of detecting all four dengue serotypes (DEN-1, DEN-2, DEN-3, DEN-4). Category: GENERAL/PRODUCT INFORMATION with kit specifications, including detection type, sensitivity, specificity, and controls. Shelf life: minimum required at delivery; Certifications: MDR 2017 compliance and a valid medical device license under the Drugs and Cosmetic Act, 1940. Pack size and packaging are specified for the kit. The procurement scope is gated by a generic option clause allowing +/-25% quantity adjustments and extended delivery windows. Location and Estimated value are not disclosed. A single PDF with product inserts is required. The tender emphasizes regulatory compliance and quality controls as differentiators.
Technical Specifications & Requirements
- Cat: Product Information; Type of Kit: Dengue ELISA kit; Serotype coverage: DEN-1, DEN-2, DEN-3, DEN-4; Detection Type: ELISA; Sensitivity and Specificity values to be provided by bidder; Controls: Positive and Negative controls included with each kit; Pack size: kit packaging details to be specified; Certifications: MDR 2017 compliance and valid medical device license under the Drugs and Cosmetic Act; Shelf life: minimum shelf life required at delivery to consignee; Additional notes reiterate product inserts provision and 4-serotype capability.
Terms & Eligibility
- Option clause allows +/-25% quantity adjustment at contract placement and during currency; delivery period extends proportionally with additional time formula, minimum 30 days; extended delivery time if needed.
- All bidders must attach product inserts of kits in a single PDF as ATC (Along with other bid documents).
- Compliance with delivery timelines, regulatory approvals, and quality controls is mandatory; bidders must submit documentation supporting MDR 2017 compliance and medical device licensing.
- The terms indicate bidders comply with procurement conditions and quantity variation mechanisms during contract execution.
Key Specifications
-
Dengue ELISA kit capable of detecting all four dengue serotypes (DEN-1 to DEN-4)
-
Detection type: ELISA-based IgM/IgG or antigen-detection as specified by bidder
-
Sensitivity and specificity percentages to be disclosed by bidder (no fixed values provided)
-
Positive and Negative controls supplied with each kit
-
Pack size: specified by bidder (kit packaging details to be provided)
-
Certifications: MDR 2017 compliance and valid medical device license under Drugs and Cosmetic Act 1940
-
Shelf life: minimum duration to be stated (as per delivery terms)
-
Documentation: product inserts must be provided in a single PDF (ATC)
Terms & Conditions
-
Option clause permitting 25% quantity variation during contract and currency
-
Delivery period adjustments follow the calculated extension formula with minimum 30 days
-
Mandatory submission of kit product inserts in a single PDF (ATC)
-
Regulatory compliance with MDR 2017 and valid medical device license required
Important Clauses
Payment Terms
Payment terms are not detailed in the provided data; bidders should expect standard govt terms and may need to confirm payment schedule during bid submission.
Delivery Schedule
Delivery period can be extended using the option clause; extended time = (additional quantity / original quantity) × original delivery period, minimum 30 days.
Penalties/Liquidated Damages
No explicit LD details provided; bidders should assume standard LD clauses will apply for late delivery or non-compliance as per government tender norms.
Bidder Eligibility
-
Demonstrated experience in supplying dengue diagnostic kits or equivalent medical devices
-
Valid GST registration and PAN
-
Financial capacity to handle procurement of kit quantities (up to the 25% variation)
-
Compliance with MDR 2017 and possession of a valid medical device license under Drugs and Cosmetic Act 1940
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
Yes
Item Category
Dengue ELISA Test Kit (Q2)
Authority Records
MINISTRY OF LABOUR AND EMPLOYMENT
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Bid Preparation
GeM Registration
Document Filing
Free consultation · 24h response
Documents 5
GeM-Bidding-9536662.pdf
Main Document
GeM Category Specification
GEM_CATEGORY_SPECIFICATION
GeM Category Specification
GEM_CATEGORY_SPECIFICATION
GeM Category Specification
GEM_CATEGORY_SPECIFICATION
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
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Tender Results
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Technical Specifications
3 Items
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| GENERAL FEATURES | Product Description | Dengue ELISA Test Kit |
| PRODUCT INFORMATION | Type of Kit | Dengue IgM Antibody ELISA Test Kit |
| PRODUCT INFORMATION | Kit should be able to detect all the 4 serotypes of dengue viruses (DEN-1, DEN-2, DEN-3, and DEN-4) | Yes |
| PRODUCT INFORMATION | Detection Type | Qualitative |
| PRODUCT INFORMATION | Sensitivity (%) | ≥99% Or higher |
| PRODUCT INFORMATION | Specificity (%) | ≥98% Or higher |
| PRODUCT INFORMATION | Positive and Negative controls provided with each kit | Yes, No |
| PACKAGING | Pack size of the kit | 96 Tests (in strips of 12 x 8 wells) |
| CERTIFICATIONS | Compliance to Medical Device Rules (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS | Availability of valid medical device license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date | Yes |
| SHELF LIFE | Minimum shelf life of the product at the time of delivery to the consignee | 3/4th of Total Shelf Life |
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Required Documents
1
GST registration certificate
2
Permanent Account Number (PAN) card
3
Experience certificates for similar dengue kit supply
4
Financial statements for the last financial year
5
EMD submission proof (amount/format to be clarified in terms)
6
Technical bid documents detailing kit specifications
7
OEM authorization (if applicable)
8
Regulatory certificates demonstrating MDR 2017 compliance
9
Valid medical device license under Drugs and Cosmetic Act 1940
10
Product inserts consolidated in a single PDF (ATC)
Frequently Asked Questions
How to bid for the dengue ELISA kit tender in ESIC India 2026
Bidders must meet MDR 2017 compliance and hold a valid medical device license; submit technical bid with kit specifications (DEN-1 to DEN-4 detection), positive/negative controls, single PDF inserts, GST, PAN, and financials. Include OEM authorizations if required and comply with the +/-25% quantity option.
What documents are required for ESIC dengue kit procurement
Required documents include GST certificate, PAN, experience certificates in similar supply, last 2-3 years financial statements, EMD proof, technical bid detailing detection type and shelf life, MDR compliance certificates, medical device license, and a single PDF with product inserts (ATC).
What are the technical specifications for the four-serotype dengue kit
Kit must detect DEN-1, DEN-2, DEN-3, and DEN-4; include positive/negative controls; specify kit packaging size; provide sensitivity and specificity values; conform to MDR 2017 and have a valid license under Drugs and Cosmetic Act 1940.
When is delivery required and how are extensions calculated
Delivery periods may extend per the option clause; extended time = (additional quantity ÷ original quantity) × original delivery period, with a minimum extension of 30 days; initial delivery schedule starts after order placement.
What certifications must the dengue ELISA kit have for ESIC tender
Bidders must provide MDR 2017 compliance certification and a valid medical device license under the Drugs and Cosmetic Act 1940; ensure product inserts are included and kit meets regulatory standards.
What is required for product inserts submission in ESIC bid
All bidders must attach all kit product inserts in a single PDF file (ATC) with the bid; ensure the PDF includes performance data, instructions, and regulatory citations relevant to the kit.
What is the scope of quantity adjustment in the ESIC dengue kit tender
The purchaser reserves the right to increase or decrease quantities up to 25% at contract placement and during the currency; maintain contracted rates, with extended delivery time as calculated by the formula.
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Documents 5
GeM-Bidding-9536662.pdf
Main Document
GeM Category Specification
GEM_CATEGORY_SPECIFICATION
GeM Category Specification
GEM_CATEGORY_SPECIFICATION
GeM Category Specification
GEM_CATEGORY_SPECIFICATION
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS