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 | 04015630946426 | 7790228001 | 7790228001 | Urisys 1100 Urine Analyzer | ROCHE DIAGNOSTICS GMBH | |
2 | 00893230002032 | KT-313 | KT-313 | Fecal Occult Blood Test | EDI™ CARE™ | EPITOPE DIAGNOSTICS INC |
3 | 00860146001527 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
4 | 00860146001510 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
5 | 00860146001503 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
6 | 00857338006934 | T1-CK50MUS | T1-CK50MUS | Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit with Mailers Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit with Mailers (Made in USA) | HEMOSURE® | HEMOSURE INC. |
7 | 00857338006323 | T1-TB50 | T1-TB50 | Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels) | HEMOSURE® | HEMOSURE INC. |
8 | 00857338006316 | T1-CM50 | T1-CM50 | Hemosure iFOB 50 Mailers Only Box Set | HEMOSURE® | HEMOSURE INC. |
9 | 00857338006309 | T1-CK30 | T1-CK30 | Hemosure iFOB Test 30 Cassettes and 50 Collection Tubes per Box Kit with Mailers | HEMOSURE® | HEMOSURE INC. |
10 | 00857338006194 | T1-TB10 | T1-TB10 | Hemosure iFOB Buffer Tube Box Set (10 Purple Cap Tubes with Short Labels) | HEMOSURE® | HEMOSURE INC. |
11 | 00857338006132 | T1-CM50 | T1-CM50 | Hemosure FOB 50 Mailers Only Box Set | HEMOSURE | HEMOSURE INC. |
12 | 00857338006125 | DUO-CM10 | DUO-CM10 | Hemosure iFOB Prepacked 10 Mailers Box Set with Two Buffer Tubes in Each Mailer | HEMOSURE® | HEMOSURE INC. |
13 | 00857338006118 | T1-TB50 | T1-TB50 | Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels) | HEMOSURE | HEMOSURE INC. |
14 | 00857338006101 | Prepack-CM25 | Prepack-CM25 | Individual Prepacked Mailer with One Tube in Each Mailer; Packed in a Plastic Bag | HEMOSURE® | HEMOSURE INC. |
15 | 00857338006095 | DUO-iFOB20 | DUO-iFOB20 | Hemosure iFOB Prepacked DUO-iFOB Test 20 Cassettes and 10 Mailers Box Kit with T Hemosure iFOB Prepacked DUO-iFOB Test 20 Cassettes and 10 Mailers Box Kit with Two Buffer Tubes in Each Mailer | HEMOSURE® | HEMOSURE INC. |
16 | 00857338006088 | T1-CK30T | T1-CK30T | Hemosure iFOB Test 30 Cassettes and 30 Collection Tubes per Box Kit without Mailer | HEMOSURE® | HEMOSURE INC. |
17 | 00857338006071 | T1-CT30 | T1-CT30 | Hemosure iFOB Test 30 Cassettes Box Set | HEMOSURE® | HEMOSURE INC. |
18 | 00857338006064 | T1-CT50 | T1-CT50 | Hemosure FOB Test 50 Cassettes Box Set | HEMOSURE® | HEMOSURE INC. |
19 | 00857338006057 | T1-CK50 | T1-CK50 | Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit without Mailer | HEMOSURE® | HEMOSURE INC. |
20 | 00857338006040 | PRE-PACK iFOB20 | PRE-PACK iFOB20 | Hemosure iFOB Prepacked iFOB Test 20 Cassettes and 20 Mailers Box Kit with One B Hemosure iFOB Prepacked iFOB Test 20 Cassettes and 20 Mailers Box Kit with One Buffer Tube in Each Mailer | HEMOSURE® | HEMOSURE INC. |
21 | 00857338006033 | T1-CK25 | T1-CK25 | Hemosure iFOB Test 25 Cassettes and 25 Collection Tubes per Box Kit without Mailer | HEMOSURE® | HEMOSURE INC. |
22 | 00857338006026 | T1-CK10 | T1-CK10 | Hemosure iFOB Test 10 Cassettes and 10 Collection Tubes per Box Kit with Mailers | HEMOSURE® | HEMOSURE INC. |
23 | 00857338006019 | T1-CK30 | T1-CK30 | contains T1-CT30, T1-TB50, T1-CM50. T1-CT30: Hemosure iFOB Test 30 Cassettes Box contains T1-CT30, T1-TB50, T1-CM50. T1-CT30: Hemosure iFOB Test 30 Cassettes Box SetT1-TB50: Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels)T1-CM50: Hemosure iFOB 50 Mailers Only Box Set | Hemosure | HEMOSURE INC. |
24 | 00855574005346 | FBPUS | Personal Use Kit OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
25 | 00855574005339 | FBT-StarterS | Starter Pack OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
26 | 00855574005322 | FOB50S | Test Kit OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
27 | 00855574005315 | FOBBTLS | Sampling Bottles OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
28 | 00855574005308 | FOBSTRS | OC-Light S Test Strips | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
29 | 00855574005193 | FBPU-BULKS | Personal Use Kit Bulk, OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
30 | 00855574005094 | FOBSTR | OC-Light Test Strips | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
31 | 00855574005070 | FOBBTL | Sampling Bottles OC-Light | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
32 | 00855574005063 | FOB50 | OC-Light Test Kit | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
33 | 00855574005056 | FBT-Starter | Starter Pack OC-Light | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
34 | 00853691007595 | 1 | FOB Rapid Test Cassette | FOB Rapid Test Cassette | ACRO BIOTECH INC | |
35 | 00850093003354 | 01 | 90035.01 | InSure® ONE™ Combo Pack - contains 35 Collection Kits and 1 Developer Kit | InSure® ONE™ | ENTERIX INC. |
36 | 00850093003323 | 01 | InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in a sealed, bulk pouch of 200 Strips (Part Number 12041.01) | InSure® ONE™ | ENTERIX INC. | |
37 | 00850093003316 | 01 | InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027 InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027.01, 15240.01, and 90010.01), 25-packs (Part Number 90025.01) and 50-packs (15030.01, 15040.01, and 90050.01) | InSure® ONE™ | ENTERIX INC. | |
38 | 00850093003309 | 01 | 90002.01 | InSure® ONE™ Sample Kit - NOT FOR SALEContains 2 Collection Kits, 2 individually InSure® ONE™ Sample Kit - NOT FOR SALEContains 2 Collection Kits, 2 individually-pouched Test Strips, and 1 bottle of Run Buffer (9mL) | InSure® ONE™ | ENTERIX INC. |
39 | 00850093003293 | 01 | 14103.01 | InSure® ONE™ Run Buffer - 1 Liter Bottle | InSure® ONE™ | ENTERIX INC. |
40 | 00850093003286 | 01 | 11018.01 | InSure® ONE™ Test Cards for QC - 50 pack | InSure® ONE™ | ENTERIX INC. |
41 | 00850093003279 | 01 | 90030.01 | InSure® ONE™ Combo Pack - contains 25 Collection Kits and 1 Developer Kit | InSure® ONE™ | ENTERIX INC. |
42 | 00850093003231 | 01 | 80025.01 | InSure® ONE™ Developer Kit - contains 25 individually-pouched Test Strips and 1 InSure® ONE™ Developer Kit - contains 25 individually-pouched Test Strips and 1 bottle of Run Buffer (9mL) | InSure® ONE™ | ENTERIX INC. |
43 | 00850093003187 | 01 | 90002 | InSure FIT Sample Kit - NOT FOR SALEContains 2 Patient Collection Kits, 2 Test S InSure FIT Sample Kit - NOT FOR SALEContains 2 Patient Collection Kits, 2 Test Strips, and 1 Run Buffer Bottle | InSure FIT | ENTERIX INC. |
44 | 00850093003095 | 01 | 14103 | InSure FIT Run Buffer - 1 Liter Bottle | InSure FIT | ENTERIX INC. |
45 | 00850093003088 | 01 | InSure FIT Test Strip | InSure FIT | ENTERIX INC. | |
46 | 00850093003071 | 01 | 11018 | InSure FIT Test Cards for QC - 50 pack | InSure FIT | ENTERIX INC. |
47 | 00850093003064 | 01 | 15022 | InSure FIT Kit | InSure FIT | ENTERIX INC. |
48 | 00850093003040 | 01 | InSure FIT Combo Pack | InSure FIT | ENTERIX INC. | |
49 | 00850093003019 | 01 | 80025 | InSure FIT Developer Kit | InSure FIT | ENTERIX INC. |
50 | 00850011007167 | TNR IFOB36 | TNR IFOB36 | Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 36/BX | Tanner Scientific® | MERCEDES MEDICAL, LLC |