Other products from "LGC CLINICAL DIAGNOSTICS, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00850011135440 508ro VALIDATE Growth Hormone IVD Control JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
2 00850011135402 510mm Validate SARS-Cov2 IgG Single clinical chemistry analyte IVD, control JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Validate
3 00850011135396 608mm Validate ISX Multiple-type clinical chemistry analyte IVD, control JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
4 00859110005999 701sa 701sa Validate UC1 is intended for the quantitative determination of Calibration Verif Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
5 00859110005982 701db 701db Validate UC1 is intended for the quantitative determination of Calibration Verif Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
6 00859110005975 701bc 701bc Validate UC1 is intended for the quantitative determination of Calibration Verif Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
7 00859110005968 701au 701au Validate UC1 is intended for the quantitative determination of Calibration Verif Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
8 00859110005951 607ro 607ro Validate Whole Blood Glucose (WBG) is intended for the quantitative determinatio Validate Whole Blood Glucose (WBG) is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Validate
9 00859110005944 605to 605to Validate HbA1c is intended for the quantitative determination of Calibration Ver Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Validate
10 00859110005937 605 605 Validate HbA1c is intended for the quantitative determination of Calibration Ver Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Validate
11 00859110005920 603ro 603ro Validate SP3 is intended for the quantitative determination of Calibration Verif Validate SP3 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
12 00859110005913 602re 602re Validate SP2 is intended for the quantitative determination of Calibration Verif Validate SP2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
13 00859110005906 602bc 602bc Validate SP2 is intended for the quantitative determination of Calibration Verif Validate SP2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
14 00859110005890 601ro 601ro Validate SP1 is intended for the quantitative determination of Calibration Verif Validate SP1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
15 00859110005883 601bcs 601bcs Validate SP1 is intended for the quantitative determination of Calibration Verif Validate SP1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
16 00859110005876 601bc 601bc Validate SP1 is intended for the quantitative determination of Calibration Verif Validate SP1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
17 00859110005869 507ro 507ro Validate LP2 is intended for the quantitative determination of Calibration Verif Validate LP2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
18 00859110005852 506vt 506vt Validate Vit D is intended for the quantitative determination of Calibration Ver Validate Vit D is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Validate
19 00859110005845 506ab 506ab Validate Vit D is intended for the quantitative determination of Calibration Ver Validate Vit D is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Validate
20 00859110005838 506 506 Validate Vit D is intended for the quantitative determination of Calibration Ver Validate Vit D is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Validate
21 00859110005821 504re 504re Validate Fertility 2 is intended for the quantitative determination of Calibrati Validate Fertility 2 is intended for the quantitative determination of Calibration Verification/Linearity of on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
22 00859110005814 502re 502re Validate Fertility 1 is intended for the quantitative determination of Calibrati Validate Fertility 1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
23 00859110005807 501vt 501vt Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
24 00859110005791 501sa 501sa Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
25 00859110005784 501ro 501ro Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
26 00859110005777 501db 501db Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
27 00859110005760 501bc 501bc Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
28 00859110005753 501au 501au Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
29 00859110005746 501ab 501ab Validate LP is intended for the quantitative determination of Calibration Verifi Validate LP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
30 00859110005739 407sa 407sa Validate Tumor Markers is intended for the quantitative determination of Calibra Validate Tumor Markers is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
31 00859110005722 407re 407re Validate Tumor Markers is intended for the quantitative determination of Calibra Validate Tumor Markers is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
32 00859110005715 406re 406re Validate PSA is intended for the quantitative determination of Calibration Verif Validate PSA is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Validate
33 00859110005708 406bc 406bc Validate PSA is intended for the quantitative determination of Calibration Verif Validate PSA is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Validate
34 00859110005692 405ro 405ro Validate High Sensitive Troponin is intended for the quantitative determination Validate High Sensitive Troponin is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
35 00859110005685 404ro 404ro Validate hsCRP is intended for the quantitative determination of Calibration Ver Validate hsCRP is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
36 00859110005678 403ro 403ro Validate PCT is intended for the quantitative determination of Calibration Verif Validate PCT is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Validate
37 00859110005661 403ab 403ab Validate PCT is intended for the quantitative determination of Calibration Verif Validate PCT is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Validate
38 00859110005654 402vt 402vt Validate CM2 is intended for the quantitative determination of Calibration Verif Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
39 00859110005647 402re 402re Validate CM2 is intended for the quantitative determination of Calibration Verif Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
40 00859110005630 402bc 402bc Validate CM2 is intended for the quantitative determination of Calibration Verif Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
41 00859110005623 402ab 402ab Validate CM2 is intended for the quantitative determination of Calibration Verif Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
42 00859110005616 401db 401db Validate CM1 is intended for the quantitative determination of Calibration Verif Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
43 00859110005609 401bc 401bc Validate CM1 is intended for the quantitative determination of Calibration Verif Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
44 00859110005593 401ab 401ab Validate CM1 is intended for the quantitative determination of Calibration Verif Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
45 00859110005586 308re 308re Validate Anemia is intended for the quantitative determination of Calibration Ve Validate Anemia is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
46 00859110005579 308bc 308bc Validate Anemia is intended for the quantitative determination of Calibration Ve Validate Anemia is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
47 00859110005562 307 307 Validate Ferritin is intended for the quantitative determination of Calibration Validate Ferritin is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Validate
48 00859110005555 205ro 205ro Validate Body Fluids is intended for the quantitative determination of Calibrati Validate Body Fluids is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
49 00859110005548 205bf 205bf Validate Body Fluids is intended for the quantitative determination of Calibrati Validate Body Fluids is intended for the quantitative determination of Calibration Verification/Linearity of on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
50 00859110005531 203vt 203vt Validate IBC is intended for the quantitative determination of Calibration Verif Validate IBC is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Validate
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
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5 10758750006977 6801751 6801751 VITROS Chemistry Products %A1c Performance Verifier II VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
6 10758750006960 6801750 6801750 VITROS Chemistry Products %A1c Performance Verifier I VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
7 10758750002702 6802349 6802349 VITROS Chemistry Products dTIBC Performance Verifier II VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
8 10758750002696 6802348 6802348 VITROS Chemistry Products dTIBC Performance Verifier I VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
9 10627966005305 C5003-2 C5003-2 RAMP® Cardiac Controls - Level 2 RESPONSE BIOMEDICAL CORP
10 10627966005299 C5003-1 C5003-1 RAMP® Cardiac Controls - Level 1 RESPONSE BIOMEDICAL CORP
11 M52551410 5141 Hi Res Protein Marker HELENA LABORATORIES CORPORATION
12 M52551360 5136 SPE Control (1 x 2 mL) HELENA LABORATORIES CORPORATION
13 M52550690 5069 LipoTrol (5 x 1 mL) HELENA LABORATORIES CORPORATION
14 M52534250 3425 SPE Abnormal Control (10 x 2 mL) HELENA LABORATORIES CORPORATION
15 M52534240 3424 SPE Normal Control (10 x 2 mL) HELENA LABORATORIES CORPORATION
16 M52518110 1811 V8 SP Abnormal Control (10 x 2 mL) HELENA LABORATORIES CORPORATION
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18 M52518050 1805 V8 Serum Protein SPE Kit (500 tests) HELENA LABORATORIES CORPORATION
19 M52514790 1479 Scale Set Solutions for AggRAM & PACKS-4 Platelet Assays HELENA LABORATORIES CORPORATION
20 08718734961499 Level 3 221.003.010 CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. CueSee® VeriSTAT QC EUROTROL B.V.
21 08718734961482 Level 2 221.002.010 CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. CueSee® VeriSTAT QC EUROTROL B.V.
22 08718734961475 Level 1 221.001.010 CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. CueSee® VeriSTAT QC EUROTROL B.V.
23 08718734961468 220.000.005 CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.A box of CueSee® VeriSTAT LVM contains 5 levels of control material:CueSee® VeriSTAT LVM Level 1 - 08718734961413CueSee® VeriSTAT LVM Level 2 - 08718734961420CueSee® VeriSTAT LVM Level 3 - 08718734961437CueSee® VeriSTAT LVM Level 4 - 08718734961444CueSee® VeriSTAT LVM Level 5 - 08718734961451 CueSee® VeriSTAT LVM EUROTROL B.V.
24 08718734960928 183.000.005 Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level.It is a convenience kit for the purposes of UDI compliance because it contains 5 different levels that are packaged together for the convenience of the user and intended to remain packaged together and not replaced, substituted, repackaged, sterilized or otherwise processed or modified before being used by an end user. Therefore, the label of each individual vial within the container is not required to bear a UDI,provided that a UDI is available on the label affixed to the immediate container of the kit. Eurotrol EUROTROL B.V.
25 08718734960911 179.003.010 Eurotrol EUROTROL B.V.
26 08718734960898 179.002.010 Eurotrol EUROTROL B.V.
27 08718734960874 179.001.010 Eurotrol EUROTROL B.V.
28 08718734960805 267.000.005 267.000.005 Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood g Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol® epoc® Calibration Verification Fluids is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. Eurotrol® epoc® Calibration Verification Fluids EUROTROL B.V.
29 08718734960799 Level 6 266.006.010 Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 6 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. Eurotrol epoc GAS-ISE Metabolites EUROTROL B.V.
30 08718734960775 Level 3 266.003.010 Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 3 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. Eurotrol epoc GAS-ISE Metabolites EUROTROL B.V.
31 08718734960751 Level 2 266.002.010 Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 2 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. Eurotrol epoc GAS-ISE Metabolites EUROTROL B.V.
32 08718734960737 Level 1 266.001.010 Eurotrol epoc® GAS-ISE Metabolites - Level 1 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 1 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 1 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. Eurotrol epoc GAS-ISE Metabolites EUROTROL B.V.
33 08430793040587 724122 The Celiac Disease IgA Controls include antibodies to tTG and DGP1. Aptiva Celia The Celiac Disease IgA Controls include antibodies to tTG and DGP1. Aptiva Celiac IgA Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives.2. Aptiva Celiac IgA Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives. Aptiva® Celiac Disease IgA Controls INOVA DIAGNOSTICS, INC.
34 08430793040525 724102 The Celiac Disease IgG Controls include antibodies to tTG and DGP.1. Aptiva Celi The Celiac Disease IgG Controls include antibodies to tTG and DGP.1. Aptiva Celiac IgG Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives.2. Aptiva Celiac IgG Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives. Aptiva® Celiac Disease IgG Controls INOVA DIAGNOSTICS, INC.
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38 08426951346448 0003310100 00003310100 Avox-4 CO-Oximeter Control, Level 1 Avox-4 CO-Oximeter Control - L1 INSTRUMENTATION LABORATORY COMPANY
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