Hemoglobin Test Strips,Anti - A Blood Grouping Reagent,Anti-B Blood Grouping Reagent (V2),Anti - D
N/a
HATHRAS, UTTAR PRADESH
Progress
Quantity
1003
Category
Anti - AB Blood Grouping Reagent (V2)
Bid Type
Single Packet Bid
The Central Government Health Scheme (CGHS) invites bids for general blood bank reagents, specifically Blood Lancets and Anti-AB Blood Grouping Reagent (Q2) categories. The tender emphasizes MDR 2017 compliance, CDSCO/NIB approvals, and valid drug licenses under the Drugs and Cosmetics Act. Bid submissions require furnishing test reports, manufacturing certifications, and license validity, with an advance sample option for buyer approval prior to supply. The procurement integrates packaging, labeling, and shelf-life obligations, ensuring reagents demonstrate high sensitivity, specificity, and clear agglutination reactions for true antigen presence or absence. A MSME/NSIC EMD exemption clause is referenced in related terms, indicating potential vendor eligibility benefits. The scope prioritizes CDSCO-compliant blood grouping reagents that do not hemolyze cells and provide observable agglutination results under standard storage conditions. This is a specialized healthcare procurement opportunity within the Indian government framework, focusing on quality control and traceability in blood banks. The unique sourcing criteria include packaging inserts, kit-level certifications, and supplier responsibility for advance sampling if requested.
General features: Blood Lancets and Anti-AB Blood Grouping Reagent (A/B antibodies) with ready-to-use formulation
Material: unspecified; Lancet cap, plastic handle details to be supplied
Needle size (Gauge): to be specified by bidder
Certification: MDR 2017 compliance, CDSCO/NIB approval, Drugs and Cosmetic Act 1940 license
Shelf life: minimum shelf life and shelf-life from manufacture to be provided
Storage: defined storage temperature range
Packaging: packing type, pack size, and packaging insert
MDR 2017 compliance and CDSCO/NIB approvals required
Licenses under Drugs and Cosmetic Act 1940 mandatory
Advance samples may be requested before supply
Not specified; implied to follow government procurement norms with possible advance payments or milestones
Delivery timelines not explicitly stated; bidders should prepare for supplier readiness per buyer requirements
Not detailed; standard government tenders apply LD provisions if delivery/default occurs
Vendor must demonstrate MDR 2017 compliance and CDSCO/NIB approvals
Valid Drugs and Cosmetics Act licensing must be shown
MSME/NSIC exemption may apply with certificate
Main Document
CATALOG Specification
CATALOG Specification
GEM_GENERAL_TERMS_AND_CONDITIONS
N/a
HATHRAS, UTTAR PRADESH
N/a
MORADABAD, UTTAR PRADESH
Southern Railway
Employees State Insurance Corporation
Employees State Insurance Corporation
Tender Results
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| Category | Specification | Requirement |
|---|---|---|
| GENERAL FEATURES | Product Description | Blood Lancets |
| PRODUCT INFORMATION | Material | Medical grade Stainless Steel and Polymer |
| PRODUCT INFORMATION | Lancet Cap | Twist Off |
| PRODUCT INFORMATION | Plastic handle | Yes |
| PRODUCT INFORMATION | Needle Size (Gauge) | 22 G, 25 G, 28 G, 30 G, 31 G, 33 G |
| CERTIFICATION & REPORTS | Compliance to Medical Device Rule (MDR) 2017 as amended till date | Yes |
| CERTIFICATION & REPORTS | 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 | 3/4 th of Total Shelf Life |
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GST registration certificate
PAN card
Experience certificates for similar blood bank reagents
Financial statements (last 3 years)
EMD/Security deposit documentation (if applicable; MSME/NSIC exemption noted)
Extended Deadline
02-Mar-2026, 10:00 am
Opening Date
02-Mar-2026, 10:30 am
Key insights about GUJARAT tender market
Bidders must meet MDR 2017 compliance, possess CDSCO/NIB approvals, and hold valid Drugs and Cosmetics Act 1940 licenses. Prepare advance samples if requested, and submit test reports, certifications, and OEM authorizations. Ensure packaging inserts are included and EMD status per MSME/NSIC eligibility.
Submit GST registration, PAN, 3-year financial statements, experience certificates for similar products, MDR test reports, manufacturing unit certification, drug licenses, and OEM authorizations. Include packaging inserts and any MSME/NSIC exemption certificates if applicable.
Reagents must be ready-to-use with A and B antibodies, provide observable agglutination for antigen-positive cells, no agglutination for negative cells, non-hemolyzing, compatible with CDSCO/NIB standards, and stored within specified temperature ranges with clear labeling and packing inserts.
Advance sample submission is requested at bid submission stage if the buyer requires prior approval. Ensure timely provision of samples to the CGHS evaluation team to facilitate demonstration of agglutination clarity and kit performance against standards.
Bidder must hold a valid drug license under the Drugs and Cosmetic Act 1940, with current validity and compliance evidence. Include license number, issuing authority, and expiry date with bid documents for verification by CGHS.
Packaging must include packing type, pack size, and a packaging insert. Reagents should meet appearance, color, sensitivity, specificity, avidity, and titer strength criteria per CDSCO/NIB approvals, with clear labeling for storage conditions and usage guidance.
Mandatory certifications include MDR 2017 compliance, CDSCO/NIB approvals, Drugs and Cosmetics Act 1940 license, and manufacturing unit certification. Suppliers must provide test reports as per MDR and ensure certification submission with bid and supply deliveries.
MSME/NSIC registered suppliers may claim EMD exemption by enclosing the respective exemption certificate. Verify validity and attach the certificate with bid documents to leverage potential exemption while meeting MDR and licensing requirements.
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Main Document
CATALOG Specification
CATALOG Specification
GEM_GENERAL_TERMS_AND_CONDITIONS