Biochemistry Reagent Kit for Human Samples,Biochemistry Reagent Kit for Human Samples,Biochemistry
Health Department
DARBHANGA, BIHAR
Posted:
11 December 2025
Closed:
22 December 2025
GEM
GEM
Indian Air Force Biochemistry Reagent Kit Tender Jammu 2026 - IS 1940 MDR 2017 Compliant Medical Device License 2026
Bid Publish Date
04-Jun-2026, 8:59 am
Bid End Date
15-Jun-2026, 9:00 am
Location
JAMMU , JAMMU & KASHMIR
Progress
Issue04-Jun-2026, 8:59 am
AwardPending
Quantity
60
Category
Biochemistry Reagent Kit for Human Samples
Bid Type
Two Packet Bid
Key Highlights
- • Regulatory framework: Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 compliance required
- • Mandatory calibrator and control: each kit pack must include a calibrator and a control
- • Medical device licensing: must hold valid Medical Device license from the competent authority
- • Delivery flexibility: purchaser may adjust quantity by up to 25% during and after initial order
- • Total volume per pack: explicit packaging volume to be verified with supplier
- • Sample compatibility: explicit mention of supported sample type and test type
Tender Overview
Organization: Indian Air Force (Department of Military Affairs) | Product: Biochemistry Reagent Kit for Human Samples (Q2) | Location: Jammu, Jammu & Kashmir - PIN 180001 | Estimated Value: not disclosed | Includes calibrator and control with each pack; total volume per pack specified; iterative quantity options may apply under contract terms. Emphasizes regulatory compliance and sample compatibility. Unique feature: routine QC components integrated per kit and MDR/Drugs Act compliance. This tender targets suppliers capable of meeting medical device licensure and end-to-end supply. Keywords: tender in Jammu, IAF procurement, reagent kit supply.
Technical Specifications & Requirements
- Product information: supports specified sample type; type of test and form of reagent per supply; calibrator and control must accompany each pack; total volume per pack stated.
- Certifications: must comply with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended; valid Medical Device license from competent authority.
- Packaging and QC: per-pack calibrator and control; consistent packing volumes; packaging quantity alignment with BOQ; ensure lot-wise traceability.
- Documentation readiness: supplier must demonstrate regulatory compliance, provide COA/COC where applicable, and maintain sample-type compatibility.
- Delivery readiness: option clause allows up to 25% quantity variation; delivery period adjustments based on order scope and extended periods as outlined.
Terms & Eligibility
- EMD/Security: amount not disclosed in data; bidders must anticipate standard government EMD documentation.
- Option clause: purchaser may increase/decrease quantity up to 25%; extended delivery time governed by (extended quantity/original quantity) × original period with a minimum of 30 days; delivery terms must be adhered to.
- ATC notes: reference to bidding terms; ensure compliance with buyer’s rights to modify quantities and delivery windows. Verification of medical device licensing and statutory compliance required.
Key Specifications
-
Biochemistry reagent kit for human samples with calibrator and control per pack
-
Total volume per pack specified in packaging details
-
Compliance with Drugs and Cosmetic Act 1940 and MDR 2017
-
Availability of valid Medical Device license for the product
-
Supported sample type and test type clearly defined in product information
-
Form of reagent, packaging dimensions, and lot-traceable labeling
Terms & Conditions
-
Mutual option to adjust order quantity up to 25%
-
Delivery timeline adjusts proportionally with extended delivery period
-
Regulatory compliance with Drugs and Cosmetic Act 1940 and MDR 2017 is mandatory
Important Clauses
Payment Terms
Payment terms not explicitly stated; bidders should anticipate standard government terms and EM/DC process per contract
Delivery Schedule
Delivery period extends from the last date of original delivery order; extended time calculated as (increased quantity/ original quantity) × original delivery period, minimum 30 days
Penalties/Liquidated Damages
Penalties not detailed in provided data; bidders should prepare for standard LD for late delivery per contract
Bidder Eligibility
-
Experience in supplying biochemical reagent kits or equivalent medical devices
-
Demonstrated regulatory compliance with MDR 2017 and Drugs Act 1940
-
Possession of valid Medical Device license for the product
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
Yes
Item Category
Biochemistry Reagent Kit for Human Samples (Q2)
Authority Records
MINISTRY OF DEFENCEMILITARY AFFAIRS DEPARTMENT
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Documents 20
GeM-Bidding-9342243.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
CATALOG-Specification-2
CATALOG Specification
CATALOG-Specification-3
CATALOG Specification
CATALOG-Specification-4
CATALOG Specification
CATALOG-Specification-5
CATALOG Specification
CATALOG-Specification-6
CATALOG Specification
CATALOG-Specification-7
CATALOG Specification
CATALOG-Specification-8
CATALOG Specification
CATALOG-Specification-9
CATALOG Specification
CATALOG-Specification-10
CATALOG Specification
CATALOG-Specification-11
CATALOG Specification
CATALOG-Specification-12
CATALOG Specification
CATALOG-Specification-13
CATALOG Specification
CATALOG-Specification-14
CATALOG Specification
CATALOG-Specification-15
CATALOG Specification
CATALOG-Specification-16
CATALOG Specification
CATALOG-Specification-17
CATALOG Specification
Buyer uploaded ATC document
ATC
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
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DARBHANGA, BIHAR
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Closed:
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GEM
Tender Results
Loading results...
Technical Specifications
17 Items
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| PRODUCT INFORMATION | Supported type of sample | Serum |
| PRODUCT INFORMATION | Type of Test | Uric Acid |
| PRODUCT INFORMATION | Form of reagent at the time of supply | Liquid |
| PRODUCT INFORMATION | Calibrator provided with each pack | No |
| PRODUCT INFORMATION | Control provided with each pack | No |
| PACKAGING | Total Volume of Reagent per Pack | 275 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 |
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Required Documents
1
GST certificate
2
PAN card
3
Experience certificates (relevant to biochemical reagent supply)
4
Financial statements (as required by tender terms)
5
EMD document or proof (as applicable per government norms)
6
Technical bid documents validating MDR 2017 and Drugs Act compliance
7
OEM authorization or vendor authorization for biochemistry reagent kits
8
Medical Device license certificate and regulatory certificates
9
COA/CoC and product specifications for each kit
10
Any other supplier qualification documents requested in terms
Frequently Asked Questions
How to bid for biochemistry reagent kit tender in Jammu IAF 2026
Bidders must submit GST, PAN, experience certificates, financial statements, and EMD as per terms. Ensure MDR 2017 and Drugs Act 1940 compliance, plus valid Medical Device license. Include OEM authorization and product specifications for calibrator and control in each kit.
What documents are required for reagent kit procurement in Jammu
Required documents include GST certificate, PAN, business license, MDR/medical device license, product COA, OEM authorization, financial statements, experience certificates, EMD proof, and technical bid as per buyer terms. Verify calibration and control component documentation per kit.
What are the technical specifications for calibrator and control for kits
Each pack must include a calibrated calibrator and an appropriate control per kit, with total volume per pack defined in packaging details. Confirm calibrator provided with each pack and control provided with each pack per product information section.
What are the regulatory compliance standards for the kit
Suppliers must comply with Drugs and Cosmetic Act 1940 and MDR 2017 as amended; possess a valid Medical Device license for the product from the competent authority, and provide regulatory certificates and traceable lot numbers.
When can quantity be increased under the option clause for delivery
The purchaser may increase quantity up to 25% of bid/contract quantity at placement and during currency; delivery time adjusts as (increased/ original) × original delivery period, with a minimum of 30 days.
What is required to prove sample type compatibility for the kit
Provide clear documentation listing supported sample type and type of test for the reagent kit; include validation or performance data showing compatibility with specified human samples.
What is the delivery schedule and penalties for late delivery
Delivery begins after the order date; if extended, time is recalculated; while LD details are not specified, bidders should assume standard LD terms and prepare performance bonds or penalties per contract.
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Documents 20
GeM-Bidding-9342243.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
CATALOG-Specification-2
CATALOG Specification
CATALOG-Specification-3
CATALOG Specification
CATALOG-Specification-4
CATALOG Specification
CATALOG-Specification-5
CATALOG Specification
CATALOG-Specification-6
CATALOG Specification
CATALOG-Specification-7
CATALOG Specification
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CATALOG Specification
CATALOG-Specification-9
CATALOG Specification
CATALOG-Specification-10
CATALOG Specification
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CATALOG Specification
CATALOG-Specification-12
CATALOG Specification
CATALOG-Specification-13
CATALOG Specification
CATALOG-Specification-14
CATALOG Specification
CATALOG-Specification-15
CATALOG Specification
CATALOG-Specification-16
CATALOG Specification
CATALOG-Specification-17
CATALOG Specification
Buyer uploaded ATC document
ATC
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS