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North Eastern Railway Biochemistry Reagent Kit for Human Samples Tender Gorakhpur Uttar Pradesh 2026

Bid Publish Date

17-Apr-2026, 6:11 pm

Bid End Date

14-May-2026, 9:00 am

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Progress

Issue17-Apr-2026, 6:11 pm
Corrigendum04-May-2026
AwardPending
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Quantity

13

Category

Biochemistry Reagent Kit for Human Samples

Bid Type

Single Packet Bid

Key Highlights

  • Manufacturer Authorization required for distributors, with full OEM details
  • Regulatory certifications: Drugs and Cosmetic Act 1940 and MDR 2017 compliance
  • Mandatory Medical Device license validity for the product
  • Advance sample approval within 7 days of contract award; non-conformity triggers modification or termination
  • Pre-dispatch or post-receipt inspection by nominated agency at buyer's discretion
  • Delivery terms may be adjusted if buyer delays sample approval; no LD for buyer delays
  • Detailed documentation: GST, PAN, experience certificates, financial statements, EMD documentation
  • BOQ shows no items; emphasis on compliance, packaging, and test type details

Categories 2

Tender Overview

The North Eastern Railway, Indian Railways unit based in Gorakhpur, Uttar Pradesh, invites bids for a Biochemistry Reagent Kit for Human Samples. The procurement scope centers on reagent kits, with compliance to regulatory frameworks and medical device licensing. Key distinguishing factors include mandatory Manufacturer Authorization, pre/post inspection options, and advance sample approval before bulk manufacturing. Although the BOQ shows no line items, bidders should prepare to supply kits that meet governing standards and be ready for sample submissions and potential acceptance testing. This opportunity is location-specific to Gorakhpur and targets suppliers of clinical reagents aligned with railway biomedical requirements.

Technical Specifications & Requirements

  • Category: PRODUCT INFORMATION; Form of reagent and Total Volume per Pack must be defined in the supplier’s proposal
  • Supported sample types and Type of Test details are required for alignment with railway testing protocols
  • Certifications: must comply with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended; valid Medical Device license for the product is mandatory
  • Compliance: must include manufacturer authorization if bidding viaAuthorized Distributors; supplier claims may trigger pre-dispatch or post-receipt inspections as designated by the Buyer
  • Quality controls: ensure documentation for regulatory compliance and readiness for advance sample approval prior to bulk supply; non-conforming samples can lead to contract termination
  • Additional product details requested in the ATC/Corrigendum (if any) should be incorporated

Terms, Conditions & Eligibility

  • EMD/Performance terms: Bidder must provide required certificates and documents; non-submission risks rejection
  • Advance sample: Submit 1 sample within 7 days of award; buyer may approve or request modifications within 7 days; delays may push delivery timelines without LD
  • Inspection: Pre-dispatch or post-receipt inspection may be conducted by nominated agency; ensure readiness for on-site checks at consignee location
  • Documentation: Provide OEM authorization, GST, PAN, experience certificates, and financial statements as per terms; ensure all certificates are current
  • Delivery/Acceptance: Bulk supply should follow approved sample specifications; deviations may lead to termination with notice
  • Compliance: Must meet all buyer ATC and corrigendum requirements; failure to upload certificates can lead to rejection

Key Specifications

  • Biochemistry reagent kit for human samples with defined total volume per pack

  • Form of reagent and packaging details must be specified by bidder

  • Compliance with Drugs and Cosmetic Act 1940 and MDR 2017; valid Medical Device license required

  • Supported type of sample and type of test to be clearly stated

  • Manufacturer authorization for distributor bids; pre/post inspection as per ATC

  • Advance sample submission and approval within 7 days of award; bulk supply post-approval

Terms & Conditions

  • Manufacturer authorization mandatory for non-OEM bids

  • Advance sample approval process with 7-day window

  • Regulatory compliance with Drugs and Cosmetic Act and MDR 2017

  • Medical Device license validity required for product

  • Inspection options (pre-dispatch or post-receipt) may apply

Important Clauses

Payment Terms

Not explicitly specified; bidders should expect standard govt terms with possible advance sample cost handling and post-delivery payment upon inspection clearance

Delivery Schedule

Delivery period to be defined post sample approval; in case of buyer delays for approval, delivery period may be refixed without LD

Penalties/Liquidated Damages

Not explicitly stated; look for LD terms in final contract and ATC if non-conformity or late delivery occurs

Bidder Eligibility

  • Experience in supplying biochemistry reagent kits for human samples

  • Capability to provide OEM authorization and maintain regulatory licenses

  • Compliance with Drugs and Cosmetic Act 1940 and MDR 2017; valid Medical Device license

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Biochemistry Reagent Kit for Human Samples (Q2)

Authority Records

MINISTRY OF RAILWAYS

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Bid Preparation GeM Registration Document Filing

Free consultation · 24h response

Documents 5

GeM-Bidding-9231639.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

CATALOG-Specification-2

CATALOG Specification

CATALOG-Specification-3

CATALOG Specification

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 3 Items

Item #1 Details

View Catalog
Category Specification Requirement
PRODUCT INFORMATION Type of Test Albumin
PACKAGING Total Volume of Reagent per Pack 440 ml
CERTIFICATIONS Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended till date Yes

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Historical Data

Required Documents

1

GST registration certificate

2

PAN card

3

OEM/Manufacturer authorization certificate

4

Experience certificates for similar biochemistry reagent kit supply

5

Financial statements (last 2-3 years)

6

EMD documentation as per tender (amount or percentage)

7

Technical bid documents demonstrating compliance with Drugs and Cosmetic Act and MDR

8

Medical Device license for the product (current)

Corrigendum Updates

2 Updates
#1

Update

04-May-2026

Extended Deadline

14-May-2026, 9:00 am

Opening Date

14-May-2026, 9:30 am

#2

Update

27-Apr-2026

Extended Deadline

30-Apr-2026, 7:00 pm

Opening Date

30-Apr-2026, 7:30 pm

Frequently Asked Questions

Key insights about UTTAR PRADESH tender market

How to bid for biochemistry reagent kit tender in Gorakhpur 2026

Bidders must submit GST, PAN, OEM authorization, and experience certificates; meet Drugs and Cosmetic Act 1940 and MDR 2017 compliance; provide Medical Device license; advance sample within 7 days; be prepared for pre/post inspection and complete documentation for the NE Railway procurement.

What documents are required for NE Railway reagent kit bid 2026

Required documents include GST certificate, PAN card, OEM authorization, 2-3 years financial statements, past experience in similar kits, EMD proof, and technical bid demonstrating regulatory compliance and packaging details per the tender.

What are the technical specifications for the reagent kit tender in Uttar Pradesh

Specifications require total volume per pack, form of reagent, tested sample type compatibility, and documentation proving compliance with Drugs and Cosmetic Act and MDR 2017; ensure kit packaging aligns with supplier’s product data and regulatory licenses.

When is advance sample submission for NE Railway reagents due

Advance sample must be submitted within 7 days of contract award; buyer will approve or request modifications within 7 days; delays can shift bulk delivery timelines without LD penalties.

What licenses are required for biochemistry reagent kit suppliers to NE Railway

Suppliers must hold a valid Medical Device license for the product and comply with MDR 2017; OEM authorization should be provided if bidding via an Authorized Distributor; ensure regulatory documentation is current.

What inspection processes may apply for the reagent kit contract

Nominated inspection agencies may conduct pre-dispatch inspection at seller premises or post-receipt inspection at consignee site; ensure readiness for inspection per ATC terms and Corrigendum if any.

How does delivery timeline adjust if buyer delays sample approval

If the buyer delays approval of the advance sample, the delivery period is refixed without liquidated damages for the period of delay; suppliers should plan contingencies for regulatory review time.

What standards and certifications must the reagents meet for NE Railway

Products must comply with Drugs and Cosmetic Act 1940 and MDR 2017, with a valid Medical Device license; supplier must provide OEM authorization and ensure packaging and test types meet railway specifications.

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