GEM

Ntpc Limited Immunoassay Analyzer Tender Bhagalpur Bihar 2025 - MDR, ISO/IEC Standards, 2017 Medical Device Rules

Posted

24 Oct 2025, 12:27 pm

Deadline

04 Nov 2025, 01:00 pm

Location

BHAGALPUR , BIHAR

Progress

Issue24 Oct 2025, 12:27 pm
AwardPending
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Quantity

1

Bid Type

Two Packet Bid

Key Highlights

  • • Model/Category: Immunoassay Analyzer (V2) with extensive test menu
  • • Standards: MDR 2017 compliance, Medical Device license under Drugs and Cosmetic Act 1940, Electrical Safety Standards
  • • Data capabilities: LIS/HIS interface, touch-screen display, inbuilt QC with LJ charts
  • • Power: VAC/Hz specification and UPS backup requirement
  • • Warranty: option for comprehensive warranty through bidding
  • • Procurement scope: SITC (Supply, Installation, Testing & Commissioning)
  • • Local preference: Class-I Local Suppliers favored under GeM terms
  • • OEM authorization: mandatory submission with bid

Categories 2

ANALYZER CHEMILUMINESCENCE

Tender Overview

Ntpc Limited invites bids for an Immunoassay Analyzer (V2) in Bhagalpur, Bihar to support comprehensive biomarker testing across cardiac, infectious, tumor, anemia, thyroid, infertility, liver, and neuro panels. The procurement covers supply, installation, testing, and commissioning with integrated data management, LIS/HIS interface, and inbuilt QC with LJ charts. Supported configurations include closed-tube and direct-tube sampling, high throughput per hour, and extensive test menus. The sale emphasizes MDR compliance, Medical Device licenses, and electrical safety, with supplier OEM authorization required. Estimated value and EMD details are not disclosed in the available data.

Technical Specifications & Requirements

  • System must support a wide test menu: Cardiac Markers, Infectious Markers, Tumor Markers, Anemia profile, Thyroid, Infertility, Infectious tests, Prenatal screening, Liver Fibrosis, Alzheimer Screening, Neuro Markers, Immuno Suppressive drugs.
  • Required system capabilities: closed-tube sampling, direct tube sampling, liquid-level sensing, clot/bubble/viscosity detection, auto-dilution, abnormal values flag, autowash, ultrasonic carryover prevention, disposable tips, dual quantitative/qualitative analysis, inbuilt reagent mixing, onboard reagent stability refrigeration.
  • Data management: touch-screen display, BID- or barcode-based sample tracking, LIS/HIS interface, inbuilt/external printer, data storage, external storage options.
  • Accessories and startup provisions: startup reagent kit, two sets of tubings, operator alerts for reagent levels and waste disposal.
  • Certification & reports: MDR 2017 compliance, Medical Device license under Drugs and Cosmetic Act, manufacturing unit certification, product test reports, electrical safety standards; vendor to submit all licenses/test reports with bid.
  • Power: VAC/Hz specification; UPS backup duration must be specified by bidder.
  • Warranty: comprehensive warranty option available in bidding, otherwise standard catalog warranty applies.

Terms, Conditions & Eligibility

  • Documentation: GSTIN, PAN, tender-specific OEM authorization, bank EFT mandate, cancelled cheque; GST rate adjustments noted post-22/09/2025; bid prices must be inclusive of all costs.
  • Scope: Supply, Installation, Testing and Commissioning (SITC).
  • Compliance: bidders must acknowledge Buyer terms; no deviations from bidding documents; all certifications and licenses to be supplied at bid submission or delivery.
  • Local preference: Class-I Local Suppliers eligible; MII purchase preference applied; GST and related taxes to be quoted inclusively.
  • Contact: store incharge and vendor grievance channels for after-sales issues; ensure OEM authorisation is included.

Key Specifications

  • Immunoassay Analyzer (V2) with wide test menu including Cardiac, Infectious, Tumor, Anemia, Thyroid, Infertility, Liver Fibrosis, Alzheimer, Neuro markers

  • System features: closed-tube and direct-tube sampling, ultrasonic carryover elimination, auto-dilution, inbuilt QC with LJ charts

  • Throughput and capacity details: per-hour throughput, sample loading capacity, and test volume per assay to be provided by bidder

  • Data management: touch screen display, handheld barcode reader, LIS/HIS interface, on-board or external printer, data storage options

  • Power & environment: VAC/Hz power, UPS duration, inbuilt/redundant refrigeration for reagents

  • Certifications: MDR 2017 compliance, Medical Device license, manufacturing unit certification, electrical safety

  • Delivery terms: SITC included; OEM authorization and all licenses to be submitted with bid

Terms & Conditions

  • EMD/price terms: bids must be inclusive of GST and all costs; quote is all-inclusive

  • Delivery & installation: SITC scope; installation testing and commissioning included

  • Warranty: comprehensive warranty option available via bidding; supersedes standard catalog warranty

Important Clauses

Payment Terms

Prices inclusive of GST, freight, insurance; no hidden charges; advance or milestones to be defined by bidder

Delivery Schedule

Delivery timelines to be provided by bidder; SITC to be completed per contract

Penalties/Liquidated Damages

Details to be provided in bid; LD to be applied for delays, non-compliance, or warranty breaches

Bidder Eligibility

  • Prior experience in immunoassay analyzer supply or similar medical devices

  • ISO/MDR compliant supplier with relevant licenses

  • OEM authorization and local supplier status as per GeM terms

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL INFORMATION Product Description Immunoassay Analyzer
PRODUCT INFORMATION Type of Configuration Benchtop
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 ≥ 200
PRODUCT INFORMATION Sample Loading Capacity at a time ≥ 30
PRODUCT INFORMATION Type of samples Serum, Plasma, Whole blood, Urine
PRODUCT INFORMATION Sample volume per test in µL ≥ 1 µL
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
Test Menu Infectious Bio Markers No
Test Menu Tests which can be performed by Bio Markers 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 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
Test Menu Thyroid profile Yes
Test Menu Tests which can be performed by thyroid profile TSH, T4, T3, FT4, FT3, TGA (Anti - tg), 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, Testosterone, AMH
Test Menu Infectious Test Yes
Test Menu Tests which can be performed for Infectious Test Anti HCV, HIV Combi
Test Menu Dual, Triple or Quad prenatal screening tests Yes
Test Menu Tests which can be performed for prenatal screening AFP (prenatal screening), HCG/ß-HCG
Test Menu Liver Fibrosis Tests No
Test Menu Tests which can be performed for Liver Fibrosis NA
Test Menu Alzheimer Screening No
Test Menu Tests which can be performed for Alzheimer Screening NA
Test Menu Neuro Markers No
Test Menu Tests which can be performed for Neuro Markers NA
Test Menu Immuno Suppressive drugs No
Test Menu Tests which can be performed for Immuno Suppressive drugs NA
SYSTEM FEATURES Closed-tube sampling Yes, No Or higher
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, No Or higher
SYSTEM FEATURES Ultrasonic wash technique to prevent carryover Yes, No Or higher
SYSTEM FEATURES Disposable tips to prevent any carryover of sample Yes, No Or higher
SYSTEM FEATURES Both quantitative and qualitative analysis of results Yes Or higher
SYSTEM FEATURES Inbuilt facility for reagent mixing 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 RFID
SYSTEM FEATURES Facility to collect both solid and liquid waste for disposal Yes
SYSTEM FEATURES Type of Calibration Automatic and Manual
SYSTEM FEATURES Calibration stability ≥ 14
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 Size of Display in inches ≥ 10 Inches
DATA MANAGEMENT Touch Screen display Yes
DATA MANAGEMENT Handheld barcode reader Yes
DATA MANAGEMENT HIS/LIS Interface RS 232 serial
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 Two set of all tubings Yes, No Or higher
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
POWER REQUIREMENTS UPS Backup in minutes NA if UPS not provided
CERTIFICATION AND REPORTS Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATION AND REPORTS Availability of 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
CERTIFICATION AND REPORTS Manufacturing unit certification ISO:13485 (Latest)
CERTIFICATION AND REPORTS Availability of Test Report for product as per Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATION AND REPORTS Electrical Safety Standards IEC 61010-1 or BIS equivalent
CERTIFICATION AND REPORTS Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission and/or along with supplies as per buyer requirement Yes
WARRANTY Warranty in years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) 3.0, 5.0

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Required Documents

1

GST registration certificate

2

PAN card copy

3

Cancelled cheque

4

Bank EFT mandate

5

OEM authorization/certificate

6

Medical Device License (Drugs and Cosmetic Act) copy

7

MDR 2017 compliance certificates

8

Electrical Safety Standards certificates

9

Test reports / Manufacturing unit certification

10

Bidder to submit all certifications and licenses at bid or delivery

Frequently Asked Questions

What documents are required for the immunoassay tender in Bhagalpur?

Bidders must submit GSTIN, PAN, OEM authorization, bank EFT mandate, cancelled cheque, and MDR compliance certificates. Include Medical Device license under Drugs and Cosmetic Act and electrical safety certificates. All licenses and test reports should be provided with bid submission and for delivery.

How to bid for Ntpc immunoassay analyzer tender in Bihar 2025?

Prepare SITC bid with supply, installation, testing, and commissioning. Include OEM authorization, MDR 2017 compliance, medical device license, and manufacturing certification. Ensure interface capabilities (LIS/HIS) and QC LJ charts are documented; quote inclusive of GST and all costs.

What are the compliance standards for this immunoassay system?

System must meet MDR 2017 compliance, Medical Device license per Drugs and Cosmetic Act, and Electrical Safety Standards. Submit certification reports, test reports, and manufacturing unit certification with bid and with delivery as required by buyer.

What is included in the SITC scope for this tender?

Scope includes supply of the immunoassay analyzer, installation, testing, commissioning, startup reagent kit, and two sets of tubings. All accessory requirements and operator alert features must be provided as part of the bid package.

What is the importance of OEM authorization in this bid?

OEM authorization demonstrates vendor's ability to supply genuine components and service within warranty terms. It is mandatory to submit with bid; without it, bid may be rejected per GeM terms and supplier eligibility rules.

When is the acceptance and warranty options for the immunoassay analyzer?

Bidders may offer a comprehensive warranty option during bidding; if selected, it supersedes standard catalog warranty. Warranty terms and duration must be clearly stated and aligned with MDR-compliant product support.

What performance data is required for data management features?

Provide LIS/HIS interface capability, touch-screen display details, bar-code reader compatibility, data storage capacity, and printer compatibility. Include display size and external storage options, plus reagent stability and calibration features.

What is the delivery and payment framework for this GeM tender?

Bid must be inclusive of all costs (GST, freight, insurance). Delivery terms specify SITC; payment terms to be defined by bidder within GeM guidelines and local procurement rules, with reference to EMD and pre-dispatch certifications.