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stat bnp control level 2  (I-Stat Corporation)

 
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    I-Stat Corporation stat bnp control level 2
    Stat Bnp Control Level 2, supplied by I-Stat Corporation, used in various techniques. Bioz Stars score: 86/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
    https://www.bioz.com/product/stat+bnp+control+level+2/2+bnp+control+i+level+stat/fda_document____cdrh_docs_slash_pdf5_slash_k053597-6-30-35
    Average 86 stars, based on 1 article reviews
    stat bnp control level 2 - by Bioz Stars, 2026-11
    86/100 stars

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    Article Title:
    Article Snippet: .. DEPARTMENT OF HEALTH & HUMAN SERVICES Pubi c Health Service Food and Drug Administration 2098 Gaither Road Rockvile MD 20850 Paul VanDerWerf, Ph.D. Director, Regulatory Affairs i-STAT Corporation 104 Windsor Center Drive JUL 2 1 20 East Windsor, NJ 08520 Re: k053597 Trade/Device Name: i-STAT BNP test i-STAT BNP Control Level 1 i-STAT BNP Control Level 2 i-STAT BNP Control Level 3 i-STAT BNP Calibration Verification Control Set Regulation Number: 21 CFR§862.1117 Regulation Name: B-type natriuretic peptide test system Regulatory Class: Class 1I Product Code: NBC, JJX Dated: June 14, 2006 Received: June 15, 2006 Dear Dr. VanDerWerf We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). ..

    Article Title:
    Article Snippet: Device Name: i-STAT® BNP Test Proprietary/Trade Name: i-STAT® BNP Test Common Name: BNP, B-Type Natriuretic Peptide Device Classification: 11 Regulation Number: CFR§ 862.1117 Panel: B-Type Natriuretic Peptide Test System Product Code: NBC .. Device Name: i-STAT® BNP Control Level 1 i-STAT® BNP Control Level 2 i-STAT® BNP Control Level 3 i-STAT® BNP Calibration Verification Control Set Proprietary/Trade Name: i-STAT® BNP Control Level 1 i-STAT® BNP Control Level 2 i-STAT® BNP Control Level 3 i-STAT® BNP Calibration Verification Control Set Common Name: BNP controls, BNP calibration verification controls Device Classification: I Regulation Number: 21 CFR§ 862.1660 Panel: Single (Specified) Analyte Controls (Assayed and Unassayed) Product Code: JJX .. Device Name: BNP test for use on the Biosite Triage® Meter.

    Article Title:
    Article Snippet: .. Controls/calibration verification controls: Device Name: i-STAT® BNP Control Level 1 i-STAT® BNP Control Level 2 i-STAT® BNP Control Level 3 i-STAT® BNP Calibration Verification Control Set Proprietary/Trade Name: i-STAT® BNP Control Level 1 i-STAT® BNP Control Level 2 i-STAT® BNP Control Level 3 i-STAT® BNP Calibration Verification Control Set Common Name: BNP controls, BNP calibration verification controls Device Classification: I Regulation Number: 21 CFR§ 862.1660 Panel: Single (Specified) Analyte Controls (Assayed and Unassayed) Product Code: JJX ..



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    stat bnp control level 2  (I-Stat Corporation)
    86
    I-Stat Corporation stat bnp control level 2
    Stat Bnp Control Level 2, supplied by I-Stat Corporation, used in various techniques. Bioz Stars score: 86/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
    https://www.bioz.com/product/stat+bnp+control+level+2/2+bnp+control+i+level+stat/fda_document____cdrh_docs_slash_pdf5_slash_k053597-6-30-35
    Average 86 stars, based on 1 article reviews
    stat bnp control level 2 - by Bioz Stars, 2026-11
    86/100 stars
    		  Buy from Supplier

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