SOLICITATION NOTICE
66 -- Clinical Analyzer
- Notice Date
- 4/27/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
- ZIP Code
- 72079-9502
- Solicitation Number
- 09-222-SOL-00024
- Archive Date
- 5/29/2009
- Point of Contact
- Julia A Savage, Phone: 303-236-3037
- E-Mail Address
-
julia.savage@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- Contracting Office Address Department of Health and Human Services, Office of Acquisition Grants Services, Bldg 20, Denver Federal Center, Denver CO 80225-0087 Description The Food and Drug Administration is soliciting for Clinical Analyzer, including water system. (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals/bids are being requested and a written solicitation will not be issued. This action is full and open competition. (ii) The solicitation number is 09-222-SOL-00024. This solicitation is issued as a Request for Quote (RFQ). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-31, April 20, 2009. (iv) This is a firm fixed price requirement. All responsible sources may submit a quote which shall be considered. The associated North American Industry Classification System (NAICS) Code is 325413. (v) Deliverables: 1. Clinical Analyzer Key Features: Analyzer -Compact fully automated random access bench top clinical analyzer. -Test channels, 40 photometric channels, 3 direct ISE channels for sodium, potassium and chloride. -Throughput-180 photometric tests per hour 270 ISE tests per hour. -Assay types, endpoint, kinetic, bichromatic, turbidimetric, sample blanking, reagent blanking and ISE (via optional integrated ISE unit). -Calibration-factor, linear, 2 point, point to point, spline, log-logit and exponential up to 7 calibrations per test. Water requirements -NCCLS type 1 or 2 purified water supply with capacity 7.5 liters per hour. -Accreditation-CE marking in compliance with in vitro diagnostics medical device directive 98/79/ec, must be or able to be FDA 510k cleared. -Sample capacity, removable tray with 40 positions for samples, calibrators and controls. -Sample identification-barcode sample identification. -Automatic sample dilution-pre-dilution and automatic re-assay with diluted, reduced or increased sample volume. -Sample pipette-dedicated sample micropipette with liquid level sensor and crash protection rinsed inside and outside with purified water. -Reagent capacity-removable tray with 40 cooled positions (20 Positions for 100, 50 or 20ml bottles and 20 positions for 20 ml bottles). -Reagent cooling- 8 to 15 degrees C. -Reagent volume- 20 to 400 ul (in 1 ul increments) -Reagent identification-automatic barcode reagent identification. -Reagent inventory-calculation of remaining reagent volume and test available alerts for reagent shortage, expired calibration. -Reagent pipette-dedicated reagent micropipette with liquid level sensor and crash detection rinsed inside and outside with purified water. -QC and calibration-daily, monthly and batch qc automatic qc, automatic calibration. 2. Service Plan: For one (1) year, to be initiated upon delivery and acceptance of equipment. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to finish required representations, or reject the terms and conditions of the solicitation, may be excluded from consideration. FOB Point Destination, with services on-site. Contract type: Commercial Item-Firm Fixed Price. Simplified procurement procedures will be utilized. (vi) The period of performance: Delivery is required 45 days after receipt of order (ARO). FOB Point of Delivery for Services and Supplies provided will be the Food and Drug Administration, 6502 S. Archer Road, Bedford, IL 60501. (vii) The provision at FAR 52.212-1 Instructions to Offerors- Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None. (viii) The government is not responsible for locating or securing any information, which is not identified in the submission. To ensure sufficient information is available, vendors must furnish as part of their proposal all descriptive material (such as cuts, illustration, drawings, or other information) necessary for the government to determine whether the product meets their requirements. (ix) Offerors must include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications- Commercial Items with its offer. (x) The clause at 52.212-4, Contract Terms and Conditions- Commercial Items, applies to this acquisition. The following addenda have been attached to the clause: None. (xi) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes of Executive Orders-Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.219-6, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-37, 52.225-1, 52.225-3, 52.225-13, and 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.acquisition.gov. CCR Requirement-Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. (xii) A standard commercial warranty on parts and workmanship is required. (xiii) The Defense Priorities and Allocations System and assigned rating are not applicable to this solicitation notice. (xiv) Applicable Numbered Note(s): None (xv) Offers are due in person, by mail or fax on or before May 14, 2009, by 15:00 hours (Mountain Standard Time-Local Prevailing Time in Denver, CO), at Food and Drug Administration OC/OSS/OFFAS, Attn: Julia Savage, Bldg 20, Denver Federal Center, POB 25087, Denver, CO 80225. ph (303) 236-3037, fax (303) 236-3100, email: Julia.Savage@fda.hhs.gov. (xvi) For information regarding this solicitation, please contact Julia Savage @ (303) 236-3037, FAX (303) 236-3100, e-mail julia.savage@fda.hhs.gov. Point of Contact Julia Savage, Admin Spec, Phone (303) 236-3037, Fax (303) 236-3100, e-mail julia.savage@fda.hhs.gov – Priscella Sullivan, Contracting Officer, Phone (214) 253-5274, e-mail priscella.sullivan@fda.hhs.gov Place of Performance Food & Drug Administration 6502 S. Archer Road Bedford, IL 60501
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=c9dcd430493bd50ae68ad27ebe14177f&tab=core&_cview=1)
- Place of Performance
- Address: 6502 S. Archer Road, Bedford, Illinois, 60501, United States
- Zip Code: 60501
- Zip Code: 60501
- Record
- SN01803130-W 20090429/090427220731-c9dcd430493bd50ae68ad27ebe14177f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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