No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00875197005936 | 07972466190 | 07972466190 | cobas Zika (480 tests) | ||||
2 | 00365702398108 | 5530199160 | 5530199160 | GJS | TEST, TIME, PROTHROMBIN | 2 | CoaguChek XS Pro Kit | |
3 | 00075537180075 | 11379194160 | 11379194160 | KHE | REAGENT, OCCULT BLOOD | 2 | Calibration Strip (Urisys 1100, cobas u 411) | |
4 | 00075537018934 | 11893467160 | 11893467160 | CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | 1 | Chemstrip 5 OB Test Strips | |
5 | 07613336215845 | 08836973160 | 08836973160 | Elecsys HIV Duo | MZF | Test, HIV detection | 2 | Elecsys HIV Duo |
6 | 07613336184615 | 09038078160 | 09038078160 | Vitamin D total G3 Elecsys cobas e 100 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
7 | 07613336179512 | 09205683001 | 09205683001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro transport line | |
8 | 07613336179499 | 09205632001 | 09205632001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro SSU | |
9 | 07613336172650 | 09038086190 | 09038086190 | Vitamin D total G3 Elecsys E2G 300 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
10 | 07613336171677 | 09007784190 | 09007784190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
11 | 07613336171660 | 09007741190 | 09007741190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
12 | 07613336170212 | 08924180160 | 08924180160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
13 | 07613336170182 | 08924163160 | 08924163160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
14 | 07613336166949 | 08836973190 | 08836973190 | MZF | Test, HIV detection | 2 | Elecsys HIV Duo | |
15 | 07613336164884 | 08764760190 | 08764760190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
16 | 07613336159804 | 04985354160 | 04985354160 | Anti-HBs CC 3 Elecsys | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | Anti-HBs CalCheck |
17 | 07613336158784 | 08463662001 | 08463662001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas c 503 analytical unit | |
18 | 07613336155332 | 08372284001 | 08372284001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
19 | 07613336155318 | 08376824190 | 08376824190 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
20 | 07613336154403 | 03500373190 | 03500373190 | MTG | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Ca Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | 3 | free PSA CalCheck | |
21 | 07613336154373 | 04491734160 | 04491734160 | tPSA reagent 200 | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
22 | 07613336154366 | 04641655160 | 04641655160 | tPSA reagent, 100 Test-Kit | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
23 | 07613336154311 | 06427405160 | 06427405160 | Anti-HCV II 200-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
24 | 07613336154304 | 06368921160 | 06368921160 | Anti-HCV II 100-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
25 | 07613336153949 | 04927931161 | 04927931161 | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | PreciControl Anti-HBc II | |
26 | 07613336147672 | 08243875190 | 08243875190 | JIT | Calibrator, secondary | 2 | CalSet PTH | |
27 | 07613336141953 | 5920353001 | 5984840001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
28 | 07613336133644 | 08105596190 | 08105596190 | NDY | TEST, CYSTATIN C | 2 | Tina-quant Cystatin C Gen.2 | |
29 | 07613336133583 | 08105529190 | 08105529190 | JZG | System, test, beta-2-microglobulin immunological | 2 | Tinaquant ß2Microglobulin | |
30 | 07613336133521 | 08105448190 | 08105448190 | DER | ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Apolipoprotein A-1 ver.2 | |
31 | 07613336130230 | 08101396190 | 08101396190 | DEM | ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant a1-Antitrypsin ver.2 | |
32 | 07613336121429 | 08058024190 | 08058024190 | JIF | ENZYMATIC METHOD, AMMONIA | 1 | Ammonia II | |
33 | 07613336121351 | 08057940190 | 08057940190 | KHP | ACID, LACTIC, ENZYMATIC METHOD | 1 | Lactate Gen.2 | |
34 | 07613336121238 | 08057648190 | 08057648190 | DBF | FERRITIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Ferritin Gen.4 | |
35 | 07613336121108 | 08057435190 | 08057435190 | KLT | ENZYME IMMUNOASSAY, CARBAMAZEPINE | 2 | ONLINE TDM Carbamazepine Gen.4 | |
36 | 07613336121061 | 08056951190 | 08056951190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Bilirubin Direct Gen.2 | |
37 | 04015630999477 | 5133181160 | 5133181160 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Elecsys Anti-CCP CalCheck | |
38 | 04015630995318 | 11776827160 | 11776827160 | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | Elecsys CalCheck FSH | |
39 | 04015630999200 | 4357221190 | 4357221190 | DLJ | CALIBRATORS, DRUG SPECIFIC | 2 | Total MPA Calibrators | |
40 | 04015630999149 | 4924495190 | 4924495190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
41 | 04015630997954 | 4642465190 | 4642465190 | LEG | ENZYME IMMUNOASSAY, VALPROIC ACID | 2 | Valproic Acid ONLINE TDM Valproic Acid | |
42 | 04015630997756 | 4490894190 | 4490894190 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
43 | 04015630996575 | 3304680190 | 3304680190 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | Preciset DAT Plus II | |
44 | 04015630995202 | 11776614190 | 11776614190 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | AFP CalCheck | |
45 | 04015630994847 | 11815601216 | 11815601216 | LGI | FLUORESCENCE POLARIZATION IMMUNOASSAY, CARBAMAZEPINE | 2 | CEDIA Carbamazepine II | |
46 | 04015630994533 | 20766356122 | 20766356122 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | LSD CalibrationControl Pack | |
47 | 04015630993468 | 20737976122 | 20737976122 | DIS | ENZYME IMMUNOASSAY, BARBITURATE | 2 | Abuscreen OnLine Barbiturates | |
48 | 04015630993284 | 11986082216 | 11986082216 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
49 | 04015630991853 | 11876899216 | 11876899216 | CFR | HEXOKINASE, GLUCOSE | 2 | Glucoquant GlucoseHK | |
50 | 04015630991778 | 11868152190 | 11868152190 | DML | NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD | 2 | Ethyl Alcohol ETH |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 06944904084985 | 105-011385-00 | Urine Standard (Indirect)(FDA) | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
2 | 06944904084978 | 105-011384-00 | Serum Standard (Indirect)(FDA) | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
3 | 05700572014294 | X0974 | Cystatin C Calibrator | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
4 | 05700572014287 | X0973 | Cystatin C Control Set | Cystatin C Control Set | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
5 | 05700572013853 | LX002 | Cystatin C Immunoparticles | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
6 | 05391516741866 | 450-11 | 450-11 | Bile Acid Calibrator Set (5 x 5 mL) | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
7 | 05391516741859 | 450-100 | 450-100 | Bile Acid Calibrator 100 umol/l (5 mL) | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
8 | 05055845400282 | FHBC100/B08176 | FHBC100/B08176 | The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quan The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent | AXIS-SHIELD DIAGNOSTICS LIMITED |
9 | 05055845400169 | FHRWR100 | FHRWR100 | The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quan The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit | AXIS-SHIELD DIAGNOSTICS LIMITED |
10 | 05055273216882 | CYS10445 | CYS10445 | Intended for in vitro diagnostic (IVD) use in the calibration of Randox Cystatin Intended for in vitro diagnostic (IVD) use in the calibration of Randox Cystatin C assay. For use in a clinical laboratory setting by trained personnel. | CYSTATIN C CALIBRATOR (CYSC CAL) | RANDOX LABORATORIES LIMITED |
11 | 05055273215557 | TF10161 | TF10161 | The Randox Soluble Transferrin Receptors Calibrator Series is intended for use i The Randox Soluble Transferrin Receptors Calibrator Series is intended for use in the calibration of Soluble Transferrin Receptors assays. | SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES (STFR CAL) | RANDOX LABORATORIES LIMITED |
12 | 05055273215540 | HA8124 | HA8124 | The HbA1c II Calibrator is intended for use in the calibration of the HbA1c II assay. | HbA1c II CALIBRATOR SET (HbA1c II CAL) | RANDOX LABORATORIES LIMITED |
13 | 05055273214550 | SC10154 | SC10154 | This product is intended for in vitro diagnostic use, in the calibration of the This product is intended for in vitro diagnostic use, in the calibration of the Randox Ransel assay. | RANSEL CALIBRATOR (RANSEL CAL) | RANDOX LABORATORIES LIMITED |
14 | 05055273213904 | AO2800 | ADIPONECTIN CALIBRATOR (ADPN CAL) | RANDOX LABORATORIES LIMITED | ||
15 | 05055273209204 | LP5047 | APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) | RANDOX LABORATORIES LIMITED | ||
16 | 05055273208733 | FR4030 | FR4030 | FRUCTOSAMINE (FRUC) | RANDOX LABORATORIES LIMITED | |
17 | 05055273208436 | CH5050 | sLDL CALIBRATOR (sLDL CAL) | RANDOX LABORATORIES LIMITED | ||
18 | 05055273208405 | CG5037 | COAGULATION CALIBRATOR (COAG CAL) | RANDOX LABORATORIES LIMITED | ||
19 | 05055273207842 | DA2700 | DA2700 | The Randox Cannabinoid Calibrator Set is intended for use in the calibration of The Randox Cannabinoid Calibrator Set is intended for use in the calibration of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. | THC CAL | RANDOX LABORATORIES LIMITED |
20 | 05055273207439 | CYS2699 | CYS2699 | The device is intended to be used for in the calibration of Cystatin C assays. | CYSC CAL | RANDOX LABORATORIES LIMITED |
21 | 05055273204520 | MA1567 | MICROALBUMIN CALIBRATOR SERIES (mALB CAL) | RANDOX LABORATORIES LIMITED | ||
22 | 05055273204285 | LO2306 | ANTI-STREPTOLYSIN O STANDARD (ASO STD) | RANDOX LABORATORIES LIMITED | ||
23 | 05055273204056 | IT3861 | IMMUNOGLOBULIN LIQUID PROTEIN CALIBRATOR (IG CAL) | RANDOX LABORATORIES LIMITED | ||
24 | 05055273203424 | GR2609 | GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL) | RANDOX LABORATORIES LIMITED | ||
25 | 05055273203110 | FR2993 | FR2993 | This product is intended for in vitro diagnostic use in the calibration of the R This product is intended for in vitro diagnostic use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. | FRUC CAL | RANDOX LABORATORIES LIMITED |
26 | 05055273201451 | CK2393 | CK2393 | The device is intended for use in the calibration of CK-MB assays in clinical ch The device is intended for use in the calibration of CK-MB assays in clinical chemistry systems. | CK-MB CAL | RANDOX LABORATORIES LIMITED |
27 | 05055273200768 | BM1362 | BETA 2 MICROGLOBULIN CALIBRATOR (B2M CAL) | RANDOX LABORATORIES LIMITED | ||
28 | 05055273200089 | AD5000 | AD5000 | The Aldolase Calibration Serum is intended for in vitro diagnostic use, in the c The Aldolase Calibration Serum is intended for in vitro diagnostic use, in the calibration of the Aldolase assay AD189. | ALS CAL | RANDOX LABORATORIES LIMITED |
29 | 05051700016698 | NK012.10S | Human IgM kit for use on SPAPLUS- Bulk Kit | THE BINDING SITE GROUP LIMITED | ||
30 | 05051700012249 | NK012.S | Human IgM kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | ||
31 | 04987486015147 | 103400 | The Calibrator 80 is for the calibration of the ADAMS A1c HA-8180 system used fo The Calibrator 80 is for the calibration of the ADAMS A1c HA-8180 system used for the quantitative determination of Hemoglobin A1c (HbA1c) in human whole blood and hemolysate samples. Bi-level calibrators (low and high) lyophilized calibrator from human-sourced hemoglobin. | Calibrator 80 | ARKRAY USA, INC. | |
32 | 04987481164475 | 999-61201 | 999-61201 | In-Vitro Diagnostic Use | uTASWako DCP Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
33 | 04987481164437 | 997-60901 | 997-60901 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
34 | 04987270234181 | 234181 | Lumipulse G HE4 Calibrators | FUJIREBIO INC. | ||
35 | 04987270234150 | 234150 | Lumipulse G BRAHMS PCT Calibrator Set | FUJIREBIO INC. | ||
36 | 04987270234020 | 234020 | Lumipulse G 25-OH Vitamin D Calibrators | FUJIREBIO INC. | ||
37 | 04987270233849 | 233849 | Lumipulse G E2-III Calibrators | FUJIREBIO INC. | ||
38 | 04987270231135 | 231135 | Lumipulse G TSH-III Calibrators | FUJIREBIO INC. | ||
39 | 04987270230954 | 230954 | Lumipulse G Prolactin Calibrators | FUJIREBIO INC. | ||
40 | 04987270230930 | 230930 | Lumipulse G FSH-N Calibrators | FUJIREBIO INC. | ||
41 | 04987270230916 | 230916 | Lumipulse G LH Calibrators | FUJIREBIO INC. | ||
42 | 04987270230893 | 230893 | Lumipulse G Progesterone-N Calibrators | FUJIREBIO INC. | ||
43 | 04987270230688 | 230688 | Lumipulse G CA125II Calibrators | FUJIREBIO INC. | ||
44 | 04987153301054 | G252GA | G252GA | Calibrator L (1 mL × 1), Calibrator H (1 mL × 1) | Calibrator for Lucica® Glycated Albumin-L | ASAHI KASEI PHARMA CORPORATION |
45 | 04560189213456 | N/A | ST AIA-PACK PROG III CALIBRATOR SET | TOSOH CORPORATION | ||
46 | 04560189213395 | N/A | ST AIA-PACK PROG II CALIBRATOR SET | TOSOH CORPORATION | ||
47 | 04560189213364 | N/A | ST AIA-PACK SHBG CALIBRATOR SET | TOSOH CORPORATION | ||
48 | 04560189213333 | N/A | AIA-PACK C-Peptide II Calibrator Set | TOSOH CORPORATION | ||
49 | 04560189213135 | N/A | ST AIA-PACK 25-OH Vitamin D CALIBRATOR SET | TOSOH CORPORATION | ||
50 | 04560189212886 | N/A | 0025328 | ST AIA-PACK BNP CALIBRATOR SET | TOSOH CORPORATION |