Immunoassay Analyzer (V2)
N/a
BILASPUR, CHHATTISGARH
Posted:
15 January 2026
Closed:
14 February 2026
GEM
GEM
Ntpc Limited Immunoassay Analyzer Tender Bhagalpur Bihar 2025 - MDR, ISO/IEC Standards, 2017 Medical Device Rules
Latest Corrigendum Available
Progress
Issue24-Oct-2025, 12:27 pm
Technical11-Apr-2025, 11:59 am
Financial
Award25-Dec-2025, 4:39 am
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
5
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
Documents 5
GeM-Bidding-8428448.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
Other Documents
OTHER
Buyer uploaded ATC document
ATC
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
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Tender Results
Loading results...
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 |
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
Corrigendum Updates
3 Updates
#1
18-Nov-2025 Update
Extended Deadline
25-Nov-2025, 1:00 pm
Opening Date
25-Nov-2025, 1:30 pm
#2
11-Nov-2025 Update
Extended Deadline
18-Nov-2025, 1:00 pm
Opening Date
18-Nov-2025, 1:30 pm
#3
04-Nov-2025 Update
Extended Deadline
11-Nov-2025, 1:00 pm
Opening Date
11-Nov-2025, 1:30 pm
Technical Results
| S.No | Seller | Item | Date | Status |
|---|---|---|---|---|
| 1 | KEDUS MEDICAL LLP Under PMA | Make : Agappe Model : Mispa i200 | 04-11-2025 11:59:48 | Qualified |
Financial Results
| Rank | Seller | Price | Item |
|---|---|---|---|
| L1 | KEDUS MEDICAL LLP Under PMA | ₹7,87,500 | Item Categories : Immunoassay Analyzer (V2) |
Contract / Result Documents 1
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Frequently Asked Questions
Key insights about BIHAR tender market
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.
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Documents 5
GeM-Bidding-8428448.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
Other Documents
OTHER
Buyer uploaded ATC document
ATC
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS