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 | 00695684321000 | 32100 | Latex slide test for C Reactive Protein | AIM CRP TEST | GERMAINE LABORATORIES, INC | |
2 | 00657498001257 | 1130-100 | 1130-100 | Latex agglutination slide test for the Qualitative and Semi-quantitative determi Latex agglutination slide test for the Qualitative and Semi-quantitative determination of C-Reactive Protein in non-diluted serum. | RaPET® CRP | STANBIO LABORATORY, L.P. |
3 | 00657498001240 | 1130-050 | 1130-050 | Latex agglutination slide test for the Qualitative and Semi-quantitative determi Latex agglutination slide test for the Qualitative and Semi-quantitative determination of C-Reactive Protein in non-diluted serum. | RaPET® CRP | STANBIO LABORATORY, L.P. |
4 | 00630414596198 | 11097631 | 11097631 | C-Reactive Protein_2 (CRP_2) Atellica CH - RGT 1000T | Atellica CH CRP_2 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
5 | 00630414552118 | 10283129 | 6522059 | CRP - ADVIA Chem. - RGT - 4x250 tests | ADVIA® Chemistry CRP_2 Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
6 | 00613647001288 | T3018-7549 | 23046389 | SURE-VUE CRP 500 TESTS/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
7 | 00613647001271 | T3018-7049 | 23038001 | SURE-VUE CRP 50TEST/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
8 | 00006136471288 | T3018-7549 | 23046389 | SURE-VUE CRP 500 TESTS/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
9 | 00006136471271 | T3018-7049 | 23038001 | SURE-VUE CRP 50TEST/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
10 | 15099590224455 | 969620 | 969620 | C-Reactive Protein Reagent (C-RP 2 x 200) | Synchron | BECKMAN COULTER, INC. |
11 | 15099590010447 | OSR6147 | CRP | AU | BECKMAN COULTER, INC. | |
12 | 10859035006016 | 71S2 | IMMUNEX CRP® | ALERE NORTH AMERICA, LLC | ||
13 | 10722355001194 | CRP-100 | A rapid undiluted latex slide test for the detection of C-Reactive Protein | Detector Lex-CRP | IMMUNOSTICS COMPANY, INC | |
14 | 10722355001187 | CRP-50 | A rapid undiluted latex slide test for the detection of C-Reactive Protein | Detector Lex-CRP | IMMUNOSTICS COMPANY, INC | |
15 | 10722355001170 | CRC-100 | A rapid color enhanced latex slide test for the detection of C-Reactive Protein | Detector C-Reactacol | IMMUNOSTICS COMPANY, INC | |
16 | 10722355001163 | CRC-50 | A rapid color enhanced latex slide test for the detection of C-Reactive Protein | Detector C-Reactacol | IMMUNOSTICS COMPANY, INC | |
17 | 08806679001520 | i-CHOMRA CRP-25 | i-CHOMRA CRP-25 | ichroma™ CRP | BODITECH MED INC. | |
18 | 08806133010099 | FPRR001 | FPRR001 | ichroma Reader | BODITECH MED INC. | |
19 | 08426950589365 | 3000-7051 | 2 x 2.5 ml REAGENT1 x 1.5 ml CONTROL +1 x 1.5 ml CONTROL –2 x 9 SLIDES | Rheumajet CRP 100 TESTS | BIOKIT, S.A. | |
20 | 07613336121191 | 08057591190 | 08057591190 | Tina-quant C-Reactive Protein IV | ROCHE DIAGNOSTICS GMBH | |
21 | 07613336121184 | 08057575190 | 08057575190 | C-Reactive Protein Gen.3 | ROCHE DIAGNOSTICS GMBH | |
22 | 05051700020152 | LK044.L.OPT.A | Optilite High Sensitivity C-Reactive Protein Kit | THE BINDING SITE GROUP LIMITED | ||
23 | 05051700020091 | NQ044.OPT.A | Optilite C-Reactive Protein Controls | THE BINDING SITE GROUP LIMITED | ||
24 | 05051700020084 | NC044.OPT.A | Optilite C-Reactive Protein Calibrator | THE BINDING SITE GROUP LIMITED | ||
25 | 05051700018456 | NK044.S.A | C-Reactive Protein Kit for SPAPLUS | THE BINDING SITE GROUP LIMITED | ||
26 | 05051700018449 | NK044.OPT.A | Optilite C-Reactive Protein Reagent | THE BINDING SITE GROUP LIMITED | ||
27 | 04987595301742 | N/A | PATHFAST hsCRP | LSI MEDIENCE CORPORATION | ||
28 | 04015630946853 | 07876432190 | 07876432190 | Tina-quant CReactive Protein IV | ROCHE DIAGNOSTICS GMBH | |
29 | 04015630946846 | 07876424190 | 07876424190 | Tina-quant CReactive Protein IV | ROCHE DIAGNOSTICS GMBH | |
30 | 04015630946839 | 07876033190 | 07876033190 | Tina-quant CReactive Protein IV | ROCHE DIAGNOSTICS GMBH | |
31 | 04015630927029 | 5401615190 | 5401615190 | Creactive protein latex) | ROCHE DIAGNOSTICS GMBH | |
32 | 04015630926916 | 5401607190 | 5401607190 | Cardiac CReactive Protein Latex High Sensitive | ROCHE DIAGNOSTICS GMBH | |
33 | 04015630925285 | 5172373190 | 5172373190 | CReactive Protein Gen3 | ROCHE DIAGNOSTICS GMBH | |
34 | 04015630923939 | 4956842190 | 4956842190 | CReactive Protein Gen3 | ROCHE DIAGNOSTICS GMBH | |
35 | 04015630923274 | 4956923190 | 4956923190 | Tinaquant CReactive Protein Gen3 | ROCHE DIAGNOSTICS GMBH | |
36 | 04015630923267 | 4956885190 | 4956885190 | Tinaquant CReactive Protein Gen3 | ROCHE DIAGNOSTICS GMBH | |
37 | 04015630913633 | 20764930322 | 20764930322 | CReactive Protein Latex) | ROCHE DIAGNOSTICS GMBH | |
38 | 00894175000312 | DACD310-100 | 310-100 | AccuDiag™CRP Latex Test KitC- Reactive Protein (CRP) latex slide test is used fo AccuDiag™CRP Latex Test KitC- Reactive Protein (CRP) latex slide test is used for the qualitative and semi-quantitative measurement of C-reactive protein (CRP) in human serum. | AccuDiag™ | DIAGNOSTIC AUTOMATION, INC. |
39 | EABA40000411 | 400-0041 | 400-0041 | The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is in The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo AmLyte 13 | ABAXIS, INC. |
40 | EABA40000351 | 400-0035 | 400-0035 | The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry an The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo BioChemistry Panel Plus | ABAXIS, INC. |
41 | EABA40000341 | 400-0034 | 400-0034 | The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemis The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo MetLyte Plus CRP | ABAXIS, INC. |
42 | 00842768014130 | 10444903 | DF34 | C-Reactive Protein Extended Range Flex® reagent cartridge, 120 tests | Dimension® Flex® reagent cartridge RCRP | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
43 | 00842768012778 | 10446604 | OWHU21 | Qualitative detection or semi-quantitative determination of C-reactive protein ( Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum | RapiTex® CRP | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
44 | 00842768011085 | 10446420 | OUAX41 | Qualitative detection or semi-quantitative determination of C-reactive protein ( Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum | RapiTex® CRP | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
45 | 00842768011078 | 10446419 | OUAX31 | Qualitative detection or semi-quantitative determination of C-reactive protein ( Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum | RapiTex® CRP | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
46 | 00842768006081 | 10445893 | K7032 | For the quantitative measurement of C-reactive protein in human serum and plasma For the quantitative measurement of C-reactive protein in human serum and plasma on the Dimension Vista® System | Dimension Vista® C-Reactive Protein Flex® reagent cartridge | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
47 | 00816057021628 | NC-505001 | NC-505001 | Detection of C-Reactive Protein | ASI CRP Control Set | ARLINGTON SCIENTIFIC, INC. |
48 | 00816057021277 | NC-6047-003G-17 | NC-6047-003G-17 | Disposable test card, generic, 17/pack | ASI Disposable Test Card | ARLINGTON SCIENTIFIC, INC. |
49 | 00816057021260 | NC-6047-003-17 | NC-6047-003-17 | Disposable Test Card, logo | ASI Disposable Test Card | ARLINGTON SCIENTIFIC, INC. |
50 | 00816057020393 | NC-5001000 | NC-5001000 | Detection of C-Reactive Protein | ASI CRP Slide Test | ARLINGTON SCIENTIFIC, INC. |