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Employees State Insurance Corporation Immunoassay Analyzer Tender India 2026 MDR 2017, ISI/ISO Compliance & Medical Device License

Bid Publish Date

12-Jun-2026, 11:50 am

Bid End Date

30-Jun-2026, 12:00 pm

EMD

₹2,45,000

Value

₹49,00,000

Location

HYDERABAD , TELANGANA

Progress

Issue12-Jun-2026, 11:50 am
AwardPending
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Quantity

1

Bid Type

Two Packet Bid

Key Highlights

  • Brand/OEM requirements for immunoassay analyzers and exact model family (V3) if specified
  • Mandatory MDR 2017 compliance and valid Medical Device license
  • 25% quantity increase/decrease clause during contract and extended delivery timing formula
  • EMD amount and submission method; data sheet alignment with technical bid
  • Penalties or performance bonds not explicitly listed; ensure clarity in contract
  • Direct tube sampling, autowash, and inbuilt quality control with LJ chart visibility
  • Power supply specifications for Indian installation sites (VAC/Hz)

Categories 5

Tender Overview

The Employees State Insurance Corporation (ESIC) invites bids for an Immunoassay Analyzer (V3) with extensive test menus including Cardiac, Infectious, Tumor, Anemia, Thyroid, Infertility, Liver Fibrosis, Neuro Markers and Immunosuppressive drug panels. Estimated value is ₹4,900,000 with an EMD of ₹245,000. The scope encompasses a high-throughput, automated benchtop analyzer capable of direct tube sampling, inbuilt QC, autowash, and onboard reagents management. Location details are unspecified; however, the procurement targets government healthcare facilities requiring MDR 2017 compliance and valid Medical Device licenses. The device must support comprehensive data management, touchscreen operation, and inbuilt or external printing capabilities. The tender emphasizes data integrity, sample traceability, and vendor ability to supply data sheets matching product specifications. A 25% quantity option during contract execution is allowed, with delivery timelines recalculated accordingly.

Technical Specifications & Requirements

  • Product category: Immunoassay Analyzer (V3) with extensive test menu
  • Throughput: system throughput per hour to be specified; must meet hospital diagnostic needs
  • Sample loading: capacity per run; direct tube sampling supported
  • System features: liquid-level sensing, clot/bubble/viscosity detection, autowash, ultrasonic carryover prevention, disposable tips, inbuilt quality control with LJ charts visible
  • Data management: touch screen display, data storage, inbuilt/external printer, external storage, startup reagent kit; LOT-specific calibration; reagent reading module
  • Certifications: MDR 2017 compliance; Drugs and Cosmetic Act 1940; Medical Device License validity; compliance with MDR licensing authority
  • Power: VAC/Hz specifications expected for India; power stability considerations
  • Accessories: startup reagent kit, operator alerts for reagent levels and waste disposal

Terms, Conditions & Eligibility

  • EMD: ₹245,000; payable as specified in tender terms
  • Experience: minimum 3 years of supplying similar immunoassay analyzers to Central/State Govt/PSU; evidence via contract copies
  • Delivery: delivery schedule contingent on option clause; delivery period adjustments up to 25% quantity change
  • Documents: mandatory Data Sheet, GST, PAN, experience certificates, financial statements, OEM authorizations
  • Compliance: Malicious Code Certificate required; Manufacturer Authorization where applicable
  • Quality/License: MDR compliance and valid Medical Device license from competent authority; Drugs & Cosmetic Act adherence

Key Specifications

  • Throughput and sample loading capacity to be specified for V3 Immunoassay Analyzer

  • Direct tube sampling capability and advanced liquid-level sensing

  • Clot, bubble, and viscosity detection with autowash and disposable tips

  • Inbuilt quality control system with visible LJ charts

  • Touch screen data management with onboard/external printer and storage

Terms & Conditions

  • EMD of ₹245,000; 3 years govt procurement experience required

  • 25% quantity up/down option during contract; delivery timing adjusts accordingly

  • MDR 2017 compliance, Drugs and Cosmetic Act 1940 adherence, valid Medical Device license

Important Clauses

Payment Terms

EMD payable as per tender; payment terms to be defined in contract; ensure alignment with delivery milestones

Delivery Schedule

Delivery period subject to option clause; additional time calculation: (increased quantity ÷ original quantity) × original delivery period, min 30 days

Penalties/Liquidated Damages

No explicit LD details provided; bidders should seek clarity on penalties for late delivery or non-conformance

Bidder Eligibility

  • Regularly manufactured and supplied similar Category Products to Govt bodies for 3 years

  • Non-liquidation, no court receivership or bankruptcy; provide undertaking

  • Data Sheet of offered product to be uploaded and matched with bid specifications

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

Yes

Item Category

Immunoassay Analyzer (V3) (Q2)

Authority Records

MINISTRY OF LABOUR AND EMPLOYMENTEMPLOYEES STATE INSURANCE CORPORATION

BID & GeM Expert Consultancy

End-to-end support — bid preparation, GeM registration, document filing & compliance by industry experts.

Bid Preparation GeM Registration Document Filing

Free consultation · 24h response

Documents 6

GeM-Bidding-9418786.pdf

Main Document

Other Documents

OTHER

Other Documents

OTHER

CATALOG-Specification-1

CATALOG Specification

Other Documents

OTHER

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
PRODUCT INFORMATION Type of Configuration Floor mounted
PRODUCT INFORMATION Type of system configuration Standalone
PRODUCT INFORMATION Type of system Closed
PRODUCT INFORMATION Processing modes Continuous random access
PRODUCT INFORMATION STAT Yes Or higher
PRODUCT INFORMATION Type of Automation Fully automated
PRODUCT INFORMATION Throughput of the system per hour ≥ 100
PRODUCT INFORMATION Sample Loading Capacity at a time ≥ 30
PRODUCT INFORMATION Type of samples Serum, Plasma, Whole blood, Urine, Body fluids
PRODUCT INFORMATION Type of method Chemiluminescence (CLIA)
Test Menu Cardiac Markers Yes
Test Menu Tests which can be performed by Cardiac Markers CK-MB, Troponin I / Troponin-T, Myoglobin, NT-proBNP, hs-cTnl, Hs - Troponin -I
Test Menu Infectious Bio Markers Yes, No
Test Menu Tests which can be performed by Bio Markers Nephrocheck, NA
Test Menu Tumor Markers Yes
Test Menu Tests which can be performed by Tumor Markers AFP, CEA, Total PSA, f-PSA, CA 125, CA 15.3, CA 19-9, IL-6
Test Menu Anemia profile Yes
Test Menu Tests which can be performed by Anemia profile Vitamin B12, Ferritin, Folate (FA)
Test Menu Bone Metabolism Yes
Test Menu Tests which can be performed by Bone metabolism Intact PTH, 25-OH Vitamin D
Test Menu Thyroid profile Yes
Test Menu Tests which can be performed by thyroid profile TSH, T4, T3, FT4, FT3, TGA (Anti - tg), TRAb, Anti - TPO, Intact PTH
Test Menu Infertility Yes
Test Menu Tests which can be performed for infertility FSH, LH, HCG/ß-HCG, PRL, Estradiol, Progesterone, Free Estriol, Testosterone, 17- OH Progesterone, AMH
Test Menu Infectious Test Yes, No
Test Menu Tests which can be performed for Infectious Test Anti HCV, Anti-HAV, Anti-HAV IgM, Anti-HBc, Anti-HBc IgM, Anti-Hbe, Anti-HBs, HBeAg, HBsAg Confirmatory, HBsAg, HIV Combi, Syphilis, HIV DUO & HCV Duo, Toxo IgG, Toxo IgM, Rubella IgG, Rubella IgM, CMV IgG, CMV IgM, HSV-1 IgG, HSV-2 IgG, NA
Test Menu Dual, Triple or Quad prenatal screening tests Yes, No
Test Menu Tests which can be performed for prenatal screening AFP (prenatal screening), Free ß - HCG, PAPP - A, HCG/ß-HCG, Free Estriol, PLGF, SFLT, NA
Test Menu Liver Fibrosis Tests Yes, No
Test Menu Tests which can be performed for Liver Fibrosis ELF, NA
Test Menu Alzheimer Screening Yes, No
Test Menu Tests which can be performed for Alzheimer Screening Beta Amyloyd, P.Tau, NA
Test Menu Neuro Markers Yes, No
Test Menu Tests which can be performed for Neuro Markers AB40, AB42, T Tau, P Tau, S100, NA
Test Menu Immuno Suppressive drugs Yes, No
Test Menu Tests which can be performed for Immuno Suppressive drugs Tacrolimus, Everolimus, Serolimus, Cyclosporin, NA
SYSTEM FEATURES Direct tube sampling Yes Or higher
SYSTEM FEATURES Liquid-level sensing Yes
SYSTEM FEATURES Clot, Bubble, Viscosity detection Yes
SYSTEM FEATURES Auto dilution Yes Or higher
SYSTEM FEATURES Abnormal values flag Yes Or higher
SYSTEM FEATURES Autowash Yes Or higher
SYSTEM FEATURES Ultrasonic wash technique to prevent carryover Yes Or higher
SYSTEM FEATURES Disposable tips to prevent any carryover of sample Yes Or higher
SYSTEM FEATURES Availability of inbuilt refrigeration system for long onboard stability of reagents Yes Or higher
SYSTEM FEATURES Module for reading reagents Barcode scanner
SYSTEM FEATURES LOT specific calibration Yes Or higher
SYSTEM FEATURES Should have inbuilt quality control system to monitor the quality results obtained and LJ charts must be visible Yes Or higher
DATA MANAGEMENT Type of data management In-built system
DATA MANAGEMENT Type of display LED/LCD/TFT
DATA MANAGEMENT Touch Screen display Yes
DATA MANAGEMENT Data Storage of sample 1000 or more
DATA MANAGEMENT Should be provided with inbuilt/external printer with necessary accessories Yes
DATA MANAGEMENT Type of External storage USB
ACCESSORIES Startup Reagent Kit to be provided Yes
ACCESSORIES Alerts for operator for level of reagents and to empty waste when indicated Yes Or higher
POWER REQUIREMENTS Type of power supply in VAC,Hz 200-240 VAC, 50-60 Hz
CERTIFICATION AND REPORTS Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATION AND REPORTS Availability of valid Medical Device license for the product issued from the competent authority Yes
CERTIFICATION AND REPORTS License issuing authority as per MDR Central Licensing Authority

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Required Documents

1

GST registration certificate

2

Permanent Account Number (PAN) card

3

Experience certificates demonstrating 3 years of similar govt-funded supply

4

Financial statements or annual reports for the last 2-3 years

5

EMD submission receipt or instrument details

6

Technical bid documents including Data Sheet alignment with product specifications

7

OEM authorization or manufacturer confirmation

8

Medical Device license and MDR compliance certificates

9

Manufacturers’/distributors’ authorization letters where applicable

Frequently Asked Questions

How to bid for immunoassay analyzer tender in India 2026 ESIC

Bidders must submit GST, PAN, experience certificates showing at least 3 years’ govt supply, financial statements, EMD ₹245,000, OEM authorization, and a product Data Sheet aligned to MDR 2017 compliance. Ensure MDR and Medical Device license validity; provide Data Sheet matching technical parameters.

What documents are required for ESIC immunoassay bid 2026

Required documents include GST certificate, PAN, 3 years govt supply contracts (with copies), financial statements, EMD proof, Data Sheet, OEM authorization, MDR compliance certificates, and Medical Device license; ensure all documents are current and match product specifications.

What are the technical specifications for the ESIC V3 analyzer

Key specs include direct tube sampling, liquid-level sensing, clot/bubble/viscosity detection, autowash, disposable tips, inbuilt QC with LJ charts, touchscreen data management, and ability to print/store data; exact throughput per hour and loading capacity must be confirmed with the Data Sheet.

What is the EMD amount for the ESIC immunoassay procurement

The EMD amount is ₹245,000, payable as specified in tender terms; submit electronic or bank guarantee per ESIC guidelines along with technical bid; ensure funds are readily available for bid submission.

What licenses and certifications are required for this ESIC tender

Bidders must demonstrate MDR 2017 compliance and possess a valid Medical Device license from the competent authority; compliance with Drugs and Cosmetic Act 1940 is mandatory; supply must be MDR-authorized and license-verified before award.

How does the 25% quantity option affect delivery for ESIC bid

The purchaser may increase or decrease quantity by up to 25% at contract placement or during currency; delivery period scales using the formula (increased quantity ÷ original quantity) × original delivery period, with a minimum of 30 days.

What payment terms accompany ESIC immunoassay supply contract

Payment terms will be defined in the final contract; bidders should expect milestone-based payments aligned with delivery acceptance and possibly upfront or post-delivery settlement; ensure clarity on payment schedule in bid submission.

What is the expected data management requirement for ESIC analyzer

The instrument must support a touchscreen display, onboard data storage, inbuilt/external printer capability, and LOT-specific calibration; ensure Data Sheet confirms data integrity features and operator alerts for reagents.

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