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In May 2006 CLINIQA obtained the highest level of ISO certification awarded to IVD companies.
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The ISO 13485 is an International Standard for Quality Systems more rigorous than ISO 9001 and designed for medical device manufacturers.
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Liquid QC™ Controls & LiniCAL® Calibration Verifiers |
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| Overview |
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 CLINIQA has channeled its proprietary liquid stabilization technology into producing the first "True Liquid" QC™ Controls and LiniCAL® Calibration Verifiers with extended refrigerated stability and lot-to-lot consistency . Liquid QC™ Controls and LiniCAL Calibration Verifiers are stored at 2-8ºC and are ready-to-use directly from the refrigerator. With CLINIQA quality "Built-In", a 2-3 year shelf life and no expensive shipping requirements, they are the ideal products for your QC Program.
 CLINIQA Liquid QC™ Controls are intended for use as quantitative control for monitoring test procedures used to assay human serum specimens for determination of specific analytes. LiniCAL® Calibration Verifiers are intended for use in the clinical laboratory to objectively verify calibration and assess linearity to monitor the manufacturer's reportable range. LiniCAL® Calibration Verifiers support CLIA and State regulatory reporting requirements when used as part of the clinical laboratories comprehensive quality control program.
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| Catalog No. |
Product |
Size |
| CLINIQA® Liquid QC™ ALCOHOL/AMMONIA CONTROL | 95501
| Alcohol/Ammonia Control Level 1
| 6 x 3 mL
| 95502
| Alcohol/Ammonia Control Level 2 | 6 x 3 mL | 95505
| Bi-Level Alcohol/Ammonia Control (Levels 1 & 2)
| 3 x 2 x 3 mL
| Analytes include: AMM, ETOH
| CLINIQA® Liquid QC™ BILIRUBIN CONTROL
| 95401
| Bilirubin Control Level 1
| 6 x 3 mL | 95402
| Bilirubin Control Level 2 | 6 x 3 mL | 95403
| Bilirubin Control Level 3 | 6 x 3 mL | 95404
| Tri-Level Bilirubin Control (Levels 1, 2 & 3)
| 2 x 3 x 3 mL | Analytes include: DBIL,TBIL, Bilirubin conjugated, Bilirubin unconjugated
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CLINIQA® Liquid QC™ CARDIAC MARKER CONTROL SP
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| 91411 |
Cardiac Marker Control SP Level 1 |
6 x 3 mL |
| 91412 |
Cardiac Marker Control SP Level 2 |
6 x 3 mL |
| 91413 |
Cardiac Marker Control SP Level 3 |
6 x 3 mL |
| 91414 |
Tri-Level Cardiac Marker Control SP (Levels 1, 2 & 3) |
2 x 3 x 3 mL |
Analytes include: CKMB, hsCRP, DIG, MYO, NT-proBNP, Tnl, TnT
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CLINIQA® Liquid QC™ UNASSAYED GENERAL CHEMISTRY
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95301
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Unassayed General Chemistry Control Level 1
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12 x 10 mL
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95302
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Unassayed General Chemistry Control Level 2 |
12 x 10 mL |
95303
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Unassayed General Chemistry Control Level 3 |
12 x 10 mL |
95304
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Tri-Level Unassayed General Chemistry Control
(Levels 1, 2 & 3)
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4 x 3 x 10 mL
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| CLINIQA® Liquid QC™ hsCRP SERUM PROTEIN CONTROL |
| 91201 |
hsCRP Serum Protein Control Level 1 |
6 x 1 mL |
| 91202 |
hsCRP Serum Protein Control Level 2 |
6 x 1 mL |
| 91203 |
hsCRP Serum Protein Control Level 3 |
6 x 1 mL |
| 91204 |
Tri-Level hsCRP Serum Protein Control (Levels 1, 2 & 3) |
2 x 3 x 1 mL |
| Analytes include: hsCRP | |
| CLINIQA® Liquid QC™ ImmuTROL® SERUM PROTEIN CONTROL |
| 91101 |
ImmuTROL Serum Protein Control Level 1 |
6 x 3 mL |
91102
| ImmuTROL Serum Protein Control Level 2 | 6 x 3 mL |
| 91103 |
ImmuTROL Serum Protein Control Level 3 |
6 x 3 mL |
| 91104 |
Tri-Level ImmuTROL Serum Protein Control
(Levels 1, 2 & 3) |
2 x 3 x 3 mL |
| 91105 |
Bi-Level ImmuTROL Serum Protein Control (Levels 1 & 3) |
2 x 2 x 3 mL |
| Analytes include: ALB, AAG, AAT, A2M, ASO, AT3, B2M, CER, C3, C4, CRP, FER, HPT, IgA, IgE, IgG, IgM, KAP, LAM, PAB, RBP, RF, TRF | |
| CLINIQA® Liquid QC™ LIPID CONTROL |
| 91501-S |
Lipid Control Level 1 |
6 x 1 mL |
| 91502-S |
Lipid Control Level 2 |
6 x 1 mL |
| 91505-S |
Bi-Level Lipid Control (Levels 1 & 2) |
3 x 2 x 3 mL |
Analytes include: Apo A1, Apo B, CHOL, HDL, LDL,TG
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| CLINIQA® Liquid QC™ TUMOR MARKER CONTROL |
| 91301 |
Tumor Marker Control Level 1 |
6 x 3 mL |
| 91302 |
Tumor Marker Control Level 2 |
6 x 3 mL |
| 91303 |
Tumor Marker Control Level 3 |
6 x 3 mL |
91304
| Tri-Level Tumor Marker Control (Level 1, 2 & 3)
| 2 x 3 x 3 mL
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Analytes include: 12 tumor markers: AFP, CEA, CA 15-3, CA19-9, CA125, CA72-4, CA 27-29, CYFRA 21-1, NSE, PSA, fPSA, Thyroglobulin, and 3 serum proteins: B2M, FER, hCG.
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| CLINIQA Liquid QC™ Controls and LiniCAL® Calibration Verifiers Product List |
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| Catalog No. |
Product |
Size |
LiniCAL® SPECIFIC PROTEIN CALIBRATION VERIFIER/LINEARTY SETS
(Levels A-E) |
| 98210 |
hsCRP for Beckman Coulter Immage/Synchron LX/DxC® |
5 x 1.5 mL |
| 98211 |
Protein 1 for Beckman Coulter Immage® |
5 x 1 mL |
| Analytes include: C3, C4, IgA, IgG, IgM, TRF |
| 98212 |
Protein 2 for Beckman Coulter Immage® |
5 x 1 mL |
| Analytes include: AAG, AAT, AMG, AT3, B2M, CER |
| 98213 |
Protein 3 for Beckman Coulter Immage® |
5 x 1 mL |
| Analytes include: ASO, CRP, FER, HPT |
| 98214 |
Protein 4 for Beckman Coulter Immage® |
5 x 1.5 mL |
| Analytes include: ALB, PAB, RF |
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| 98201 |
Protein 1 for Beckman Coulter Array® |
5 x 1 mL |
| Analytes include: C3, C4, IgA, IgG, IgM, TRF |
| 98202 |
Protein 2 for Beckman Coulter Array® |
5 x 2 mL |
| Analytes include: AAG, AAT, AMG, AT3, B2M, CER |
| 98203 |
Protein 3 for Beckman Coulter Array® |
5 x 1 mL |
| Analytes include: ASO, CRP, HPT |
| 98204 |
Protein 4 for Beckman Coulter Array® |
5 x 1.5 mL |
| Analytes include: ALB, PAB, RF |
| 98205 |
Protein 5 for Beckman Coulter Array®/Immage® |
5 x 1 mL |
| Analytes include: Micro Albumin |
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| 98501 | Protein 1 for Roche Integra™/Hitachi
| 6 x 1 mL
| | Analytes include: C3, C4, IgA, IgG, IgM, TRF |
| 98502 |
Protein 2 for Roche Integra™/Hitachi |
5 x 1 mL |
| Analytes include: AAG, AAT, B2M, CER |
| 98503 |
Protein 3 for Roche Integra™/Hitachi |
6 x 1 mL |
| Analytes include: ASO, CRP, HPT, IRON |
98504
| Protein 4 for Roche Integra™/Hitachi
| 6 x 1 mL
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Analytes include: ALB, PAB, RF II
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| LiniCAL® CALIBRATION VERIFIER/LINEARITY SETS FOR BECKMAN COULTER SYNCHRON® |
| 98221 |
General Chemistry |
5 x 2 mL |
| Analytes include: ALB, BUN, CA, CL, CREA, FE, GLU, K , LAC, MG, NA, PHOS, TG, TP |
| 98224 |
Bilirubin |
5 x 1 mL |
| Analytes include: DBIL, TBIL |
| 98225 |
Enzymes |
5 x 2 mL |
| Analytes include: ALP, ALT, AMY, AST, CHE, CK, CK-MB, GGT, LD-L, LIPA, PAMY |
| 98226 |
Esoterics
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5 x 1 mL |
| Analytes include: AMM, ETOH, MA, M-TP, SALY |
| 98227 |
Immunoproteins |
6 x 1 mL |
| Analytes include: ASO, IgA, IgG, IgM, PAB,TRF |
| 98228 |
RF and CRP |
5 x 1 mL |
| Analytes include: CRP, RF |
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| LiniCAL® CALIBRATION VERIFIER/LINEARITY SETS FOR OLYMPUS AU SYSTEMS |
| 98300 | hsCRP for Olympus AU Systems | 5 x 1.5 mL | | 98301 | Protein 1 for Olympus AU Systems | 5 x 1 mL | | Analytes include: RF | | 98302 | Protein 2 for Olympus AU Systems | 5 x 1.5 mL | | Analytes include: ASO, C3, C4, CRP, FER, IgA, IgG, IgM, PAB, TRF | | 98303 | Protein 3 for Olympus AU Systems | 5 x 1.5 mL | | Analytes include: AAG, AAT, B2M, HPT | | 98304 | Bilirubin | 5 x 3 mL | | Analytes include: DBIL, TBIL | | 98305 | Enzymes | 5 x 3 mL | | Analytes include: ALP, ALT, AMY, AST, CHE, CK, CK-MB, GGT, LD-L, LIPA | | 98306 | Esoterics
| 5 x 3 mL | Analytes include: AMM, ETOH, MA, M-TP, SALY
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| 98307 |
General Chemistry |
5 x 3 mL |
| Analytes include: ALB, BUN, CA, CL, CREA, FE, GLU, K , LAC , MG, NA, PHOS, TG, TP |
| 98308 |
TDM |
5 x 3 mL |
| Analytes include: ACTM, AMIK, CAFF, CAR, DIG, DISO, ETHO, GEN, LIDO, LI, NAPA, PHE, PHY, PRIM, PROC, QUIN, SALY, THE, TOB, VPA, VANC |
| 98311 |
Uric Acid |
5 x 2 mL |
Analytes include: UA
| 98312
| Bicarbonate & Electrolytes
| 5 x 3 mL
| | Analytes include: CO2, CL, NA, K | |
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LiniCAL® kits are stored at 2-8ºC with the exception of Enzymes that are kept at -20ºC.
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