Biochemistry Reagent Kit for Human Samples,Biochemistry Reagent Kit for Human Samples,Biochemistry
N/a
Posted:
10 October 2025
Closed:
20 October 2025
GEM
GEM
Directorate Of Purchase And Stores Biochemistry Reagent Kit for Human Samples Tender Mumbai Maharashtra 2026
Bid Publish Date
23-Feb-2026, 6:08 pm
Bid End Date
11-Mar-2026, 1:00 pm
Location
Progress
Issue23-Feb-2026, 6:08 pm
AwardPending
Quantity
60
Category
Biochemistry Reagent Kit for Human Samples
Bid Type
Two Packet Bid
Categories
2
Tender Overview
The Directorate Of Purchase And Stores under the Department Of Atomic Energy in Mumbai, Maharashtra invites bids for a Biochemistry Reagent Kit for Human Samples. The procurement includes reagent packs with calibrator and control, and specifies total volume per pack, sample compatibility, test type, and pack form. Key compliance involves Drugs and Cosmetic Act 1940 and Medical Device Rules 2017, plus a valid Medical Device license and traceability certificate for calibrators. Logistics require non-GPS vehicles and delivery windows within purchaser premises between 1100-1245 and 1400-1700 hours, Monday to Friday. The bid scope focuses on supply of goods only, with certificates mandatory to avoid rejection. Packaging and QA features differentiate this lot through calibrator/control provisions and traceability documentation.
Technical Specifications & Requirements
- Product information: Supported sample type; Type of test; Form of reagent at supply; Calibrator provided with each pack; Control provided with each pack; Total volume of reagent per pack
- Certifications: Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017; Valid Medical Device license; Traceability certificate with calibrators
- Additional notes: Repeats across categories indicate emphasis on calibator/control inclusion, packaging volumes, and regulatory approvals; delivery terms require non-GPS vehicles and time-bounded handover at buyer premises; scope is restricted to supply of goods only.
Terms, Conditions & Eligibility
- Scope: Only supply of goods; complete bid price must include all costs
- Certificates must be uploaded as required in bid document, ATC and corrigenda
- Compliance with rule 144(Xi) GFR 2017 on procurement from land-border country restrictions
- GPS-free delivery vehicle requirement; delivery windows 1100-1245 and 1400-1700 hours, Mon-Fri
- Packages must contain GEM contract number and other relevant details
Key Specifications
-
Product: Biochemistry Reagent Kit for Human Samples
-
Includes: Calibrator with each pack; Control with each pack
-
Total volume per pack: not specified in data
-
Certifications: MDR 2017 compliance; Drugs and Cosmetic Act 1940; valid Medical Device license
-
Traceability certificate provided with calibrators
-
Sample compatibility and test type are required but specifics not enumerated
Terms & Conditions
-
Delivery only of goods; no installation services
-
Non-GPS vehicles only for dispatch; delivery timing windows
-
Mandatory MDR 2017 and Drugs & Cosmetic Act compliance; Medical Device license
Important Clauses
Payment Terms
Not specified in data; standard supplier terms apply per bid document
Delivery Schedule
Delivery to purchaser premises restricted hours: 1100-1245 and 1400-1700, Monday to Friday; GPS-free vehicles required
Penalties/Liquidated Damages
Not specified in data; follow evaluation guidelines and contract terms
Bidder Eligibility
-
Must comply with GFR 2017 restrictions on land-border procurement
-
Demonstrate MDR 2017 compliance for biochemistry reagents
-
Submit valid Medical Device license and calibrator traceability certificates
Documents 5
GeM-Bidding-8864402.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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Tender Results
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Technical Specifications
3 Items
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| PRODUCT INFORMATION | Supported type of sample | Serum |
| PRODUCT INFORMATION | Type of Test | Triglyceride |
| PRODUCT INFORMATION | Form of reagent at the time of supply | Liquid |
| PRODUCT INFORMATION | Calibrator provided with each pack | Yes |
| PRODUCT INFORMATION | Control provided with each pack | No |
| PACKAGING | Total Volume of Reagent per Pack | 100 ml |
| CERTIFICATIONS | Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS | Availability of valid Medical Device license for the product issued from the competent authority | Yes |
| CERTIFICATIONS | Availability of Traceability certificate provided with the calibrators | Yes |
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Required Documents
1
GST registration certificate
2
PAN card
3
Experience certificates (biochemistry/medical devices preferred)
4
Financial statements (as applicable)
5
EMD/Security deposit documentation (if applicable)
6
Technical bid documents demonstrating MDR/IS certifications or equivalent
7
OEM authorizations or approvals for biochemistry reagents
8
Medical Device license and traceability certificates for calibrators
Frequently Asked Questions
Key insights about MAHARASHTRA tender market
How to bid for Mumbai biochemistry reagent tender with MDR compliance
Bidders must submit MDR 2017 compliant reagents with valid Medical Device license, traceability certificates for calibrators, and packaging details. Upload GST, PAN, experience certificates, and OEM authorizations. Ensure non-GPS vehicle delivery and comply with specified delivery windows (1100-1245; 1400-1700).
What documents are required for the Mumbai reagent kit tender
Required documents include GST registration, PAN, experience certificates, financial statements, EMD documentation if applicable, technical compliance certificates, OEM authorizations, and the Medical Device license with traceability certificates for calibrators. Ensure all certifications are uploaded with the bid.
What are the essential technical specifications for the reagent kit
Key specs include reagent form, calibrator and control inclusion with each pack, total volume per pack, and confirmation of sample compatibility and test type. Compliance with MDR 2017 and Drugs Act is mandatory, along with traceability certificates for calibrators.
When are deliveries expected at the purchaser premises in Mumbai
Deliveries must occur within the time windows: 1100-1245 hours and 1400-1700 hours, Monday to Friday. Use non-GPS vehicles for dispatch and label consignments with GEM contract number and relevant details for tracking.
What are the EMD requirements for this reagent bid
EMD requirements are not specified in the data. Bidder should verify in the bid document and atc corrigendum; prepare typical EMD via demand draft or online payment as per organization norms.
Which certifications ensure regulatory compliance for the kit
Essential certifications include compliance to Drugs and Cosmetic Act 1940, Medical Device Rules (MDR) 2017, a valid Medical Device license, and traceability certificates provided with calibrators to verify lot authenticity.
What scope of supply is required for this tender in Mumbai
Scope is limited to the supply of goods only; no installation or services. The bid must include all costs for delivering reagent kits, including calibrator and control materials, under a single contract price.
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Documents 5
GeM-Bidding-8864402.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