No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00365702702684 | 09397116001 | 09397116001 | IWL Lancets 10ct | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | 2 | Instant White Label |
2 | 00365702710108 | 07453710001 | Accu-Chek Guide 25ct Strip 36/cs | LFR | Glucose Dehydrogenase, Glucose | 2 | Accu-Chek Guide | |
3 | 00365702702660 | 09556672001 | 09556672001 | Relion Platinum Lancing Device | QRL | Multiple Use Blood Lancet For Single Patient Use Only | 2 | RELION |
4 | 00365702702431 | 08387052001 | ACCU-CHEK GUIDE ME MG/DL METER 897 (US) | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Accu-Chek Guide | |
5 | 00365702726109 | 08053723001 | Accu-Chek Guide Mail Order 50 ct | LFR | Glucose Dehydrogenase, Glucose | 2 | Accu-Chek Guide | |
6 | 00365702719101 | 08256292001 | Accu-Chek Guide 50ct HN 36/cs | LFR | Glucose Dehydrogenase, Glucose | 2 | Accu-Chek Guide | |
7 | 00365702729100 | 08453071001 | Accu-Chek Guide Retail Kit FCN mg/dl US | NBW | System, Test, Blood Glucose, Over The Counter | Accu-Chek Guide | ||
8 | 00365702728103 | 08453063001 | Accu-Chek Guide Sample Kit FCN mg/dl US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Accu-Chek Guide | |
9 | 00365702609105 | 07398794001 | ACCU-CHEK GUIDE MG/DL METER 923 (US) | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Accu-Chek Guide | |
10 | 00365702508101 | 06604765001 | 06604765001 | ACCU-CHEK 360 INSULIN PUMP CONFIG SW US | MRZ | Accessories, Pump, Infusion | 2 | ACCU-CHEK 360 |
11 | 00365702457102 | 05959551001 | 05959551001 | ACCU-CHEK PERFORMA PROF METER KIT US F2 | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ACCU-CHEK PERFORMA |
12 | 00365702702394 | 08340331001 | ACCU-CHEK AVIVA MG/DL 455 US NON-VA | LFR | Glucose Dehydrogenase, Glucose | 2 | Accu-Chek Aviva | |
13 | 00365702723108 | 08350051001 | Accu-Chek Aviva Plus Retail Kit 10/case | NBW | System, Test, Blood Glucose, Over The Counter | Accu-Chek Aviva | ||
14 | 00365702897106 | 03789721001 | 03789721001 | Accu-Chek Softclix Mailorder 100ct 12/cs | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Accu-Chek Softclix | |
15 | 00365702700123 | 09275371001 | 09275371001 | Accu-Chek Softclix AST Kit USA | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Accu-Chek Softclix | |
16 | 00365702400108 | 05509661001 | 05509661001 | Accu-Chek Softclix (black) USA 12/case | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Accu-Chek Softclix | |
17 | 00365702156104 | 04980263001 | 04980263001 | Accu-Chek Softclix HN Lancets 100ct 12cs | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Accu-Chek Softclix | |
18 | 00075537009710 | 11893238160 | 11893238160 | Accu-Chek Softclix Lancets 100ct 12/cs | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Accu-Chek Softclix | |
19 | 04015630084937 | 03144844001 | 03144844001 | Accu-Chek Softclix Lancets 10/pk | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | 2 | Accu-Chek Softclix |
20 | 04015630082209 | 05181186001 | 05181186001 | Accu-Chek Softclix Black Bulk 100 | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | 2 | Accu-Chek Softclix |
21 | 00365702700932 | 06908420002 | VIAL LBLD 10CT STRIP AC AVIVA PLUS BRK | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS | |
22 | 00365702712102 | 07453744001 | 07453744001 | ACCU-CHEK GUIDE 100CT STRIP 24/CS | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK GUIDE | |
23 | 00365702701236 | 06444393001 | Accu-Chek Compact Plus Control L2 (Bio)The UDI information was not placed on the Accu-Chek Compact Plus Control L2 (Bio)The UDI information was not placed on the vial label due to the new kit guidance that was published. | LFR | Glucose Dehydrogenase, Glucose | 2 | Accu-Chek Compact Plus | |
24 | 00365702733107 | 08499918001 | Accu-Chek Guide Me Smpl Kit FC mg/dl US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Accu-Chek Guide Me | |
25 | 00365702732100 | 08499900001 | Accu-Chek Guide Me Meter Only mg/dl US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Accu-Chek Guide Me | |
26 | 00365702731103 | 08499896001 | Accu-Chek Guide Me Retail Kit mg/dl US | NBW | System, Test, Blood Glucose, Over The Counter | Accu-Chek Guide Me | ||
27 | 00365702730106 | 08499888001 | ACCU-CHEK GUIDE ME HNP KIT MG/DL US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ACCU-CHEK GUIDE ME | |
28 | 00365702702219 | 07531567160 | 07531567160 | Accu-Chek Fastclix AST Kit USA | QRL | Multiple Use Blood Lancet For Single Patient Use Only | Accu-Chek Fastclix | |
29 | 00365702702196 | 03450074001 | 03450074001 | Accu-Chek Safe-T-Pro Plus 5ct | FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 | Accu-Chek Safe-T-Pro |
30 | 00365702702141 | 08029016160 | 08029016160 | Accu-Chek Safte-T-Pro Plus 200ct Coag 6/cs | FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 | Accu-Chek Safe-T-Pro |
31 | 00365702702066 | 07400942001 | 07400942001 | ACCU-CHEK GUIDE METER ONLY MG/DL US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ACCU-CHEK GUIDE |
32 | 00365702702042 | 07400926001 | 07400926001 | ACCU-CHEK GUIDE RETAIL KIT MG/DL | NBW | System, Test, Blood Glucose, Over The Counter | ACCU-CHEK GUIDE | |
33 | 00365702702035 | 07400870001 | 07400870001 | ACCU-CHEK GUIDE SAMPLE KIT MG/DL | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ACCU-CHEK GUIDE |
34 | 00365702701977 | 07453701001 | 07453701001 | ACCU-CHEK GUIDE 10CT STRIP 36/CS | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK GUIDE | |
35 | 00365702701953 | 07453736001 | 07453736001 | ACCU-CHEK GUIDE 50CT STRIP 36/CS | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK GUIDE | |
36 | 00365702701908 | 08053774001 | 08053774001 | VIAL LBLD 10CT STRIP ACCU-CHEK GUIDE | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK GUIDE |
37 | 00365702700475 | 06372481160 | 06372481160 | Accu-Chek Safe-T-Pro Uno 10ct | FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 | Accu-Chek Safe-T-Pro |
38 | 00365702700468 | 05888662160 | 05888662160 | Accu-Chek Safe-T-Pro Uno 200ct 16/cs | FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 | Accu-Chek Safe-T-Pro |
39 | 00365702688100 | 07748906001 | ACCU-CHEK GUIDE 2-LEVEL CONTROLS US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | ACCU-CHEK GUIDE | ||
40 | 00365702544109 | 06870287001 | ACCU-CHEK AVIVA MG/DL 455 US | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA | |
41 | 00365702481107 | 05864666160 | 05864666160 | Accu-Chek Fastclix MO/RP/AST Kit USA | QRL | Multiple Use Blood Lancet For Single Patient Use Only | Accu-Chek Fastclix | |
42 | 00365702438101 | 06908349001 | 06908349001 | ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS |
43 | 00365702437104 | 06908314001 | 06908314001 | ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK AVIVA PLUS | |
44 | 00365702436107 | 06908373001 | ACCU-CHEK AVIVA PLUS 50 MLRDR BRK 36/CS | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS | |
45 | 00365702408104 | 06908268001 | 06908268001 | ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK AVIVA PLUS | |
46 | 00365702407107 | 06908217001 | 06908217001 | ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS |
47 | 00365702405103 | 06908152001 | 06908152001 | ACCU-CHEK AVIVA PLUS 10CT STRIP BRK | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS |
48 | 00365702291102 | 05360188001 | 05360188001 | Accu-Chek Fastclix 102 Lancets DME 12/cs | QRL | Multiple Use Blood Lancet For Single Patient Use Only | Accu-Chek Fastclix | |
49 | 00365702288102 | 05360145001 | 05360145001 | Accu-Chek Fastclix 102 Lancets Rtl 12/cs | QRL | Multiple Use Blood Lancet For Single Patient Use Only | Accu-Chek Fastclix | |
50 | 00365702220102 | 05177294001 | ACCU-CHEK COMPACT PLUS DME KIT | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ACCU-CHEK COMPACT PLUS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00817302023046 | DT243 | DT243 | CREA (Creatinine) 4 x 400 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CREA REAGENT PRODUCT NO. DT243 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
2 | 00817302022131 | CC612 | CC612 | FRUC (Fructosamine) w/ cal 2 x 40 tests | CAROLINA LIQUID CHEMISTRIES CORP.™ FRUC FRUCTOSAMINE CC612 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
3 | 00817302022124 | AU-612 | AU-612 | FRUC (Fructosamine) w/ cal 3 x 80 tests | CAROLINA LIQUID CHEMISTRIES CORP.® FRUC RGT. KIT AU-612 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
4 | 00817302022117 | CC030 | CC030 | FRUC (Fructosamine) Control | CAROLINA LIQUID CHEMISTRIES CORP.® FRUC CONTROL SET CC030 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
5 | 00817302020175 | ST500 | ST500 | Vitamin D-direct w/ cal 1 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D CONTROL SET | CAROLINA LIQUID CHEMISTRIES CORPORATION |
6 | 00817302020168 | ST501 | ST501 | Vitamin D-direct control 2 x 2 mL (2 lev) | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D RGT KIT Product No. ST500 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
7 | 00817302020151 | CC204-100-D | CC204-100-D | Lp(a) (Lipoprotein (a) 2 x 60 tests | CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D | CAROLINA LIQUID CHEMISTRIES CORPORATION |
8 | 00817302020144 | AU-204-D | AU-204-D | Lp(a) (Lipoprotein (a) 3 x 400 tests | CAROLINA LIQUID CHEMISTRIES CORP.® LP(a)-D RGT. KIT AU-204-D | CAROLINA LIQUID CHEMISTRIES CORPORATION |
9 | 00817302020137 | BL204 | BL204 | Lp(a) (Lipoprotein (a) 2 x 130 tests | CAROLINA LIQUID CHEMISTRIES CORP.® LP(a) RGT. KIT BL-204 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
10 | 00817302020120 | CC202 | CC202 | HCY (Homocysteine) w/ cal 2 x 60 tests | CAROLINA LIQUID CHEMISTRIES CORP.™ HCY HOMOCYSTEINE REAGENT CC202 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
11 | 00817302020113 | CC053 | CC053 | HCY (Homocysteine) Level 3 control 6 x 5 mL | CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 3 CONTROL KIT PART# CC053 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
12 | 00817302020106 | CC052 | CC052 | HCY (Homocysteine) Level 2 control 6 x 5 mL | CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 2 CONTROL KIT PART# CC052 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
13 | 00817302020090 | CC051 | CC051 | HCY (Homocysteine) Level 1 control 6 x 5 mL | CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 1 CONTROL KIT PART# CC051 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
14 | 00817302020069 | CC691 | CC691 | CYST (Cystatin-C) 2 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CYST CYSTATIN CC691 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
15 | 00817302020052 | BL343 | BL343 | CREAu (Creatinine, Urine) only | CAROLINA LIQUID CHEMISTRIES CORP.® UCREA RGT. KIT BL-343 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
16 | 00817302020045 | BL243 | BL243 | CREA (Creatinine) 3 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CREA RGT. KIT BL-243 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
17 | 00817302020038 | ST243 | ST243 | CREA (Creatinine) 4 x 250 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CREATININE REAGENT KIT | CAROLINA LIQUID CHEMISTRIES CORPORATION |
18 | 00817238011032 | R85321 | Fructosamine Calibrator | Fructosamine Calibrator | CLINIQA CORPORATION | |
19 | 00817238010783 | 85962 | Hemoglobin A1c Calibrators | Hemoglobin A1c Calibrators | CLINIQA CORPORATION | |
20 | 00817238010394 | 91819 | DIABETES CONTROL SAMPLE PACK | DIABETES CNTL, Smpl, 1x2x0.5mL | CLINIQA CORPORATION | |
21 | 00817238010387 | 91815 | DIABETES CONTROL BI-LEVEL | DIABETES CNTL, Bi-L | CLINIQA CORPORATION | |
22 | 00817238010035 | 91494 | CLINIQA Liquid QCTM CoV-2 IgG Control an un-assayed quality control material for CLINIQA Liquid QCTM CoV-2 IgG Control an un-assayed quality control material for SARS-CoV-2 IgG assays. | LiquidQC CoV-2 IgG Control | CLINIQA CORPORATION | |
23 | 00816784020987 | 0505-0159 | AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome (Positive and Negative AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome (Positive and Negative member-5 X 1.5 ml) | AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome | LGC CLINICAL DIAGNOSTICS, INC. | |
24 | 00816784020970 | 2015-0225 | ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 2000 | ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 2000 | LGC CLINICAL DIAGNOSTICS, INC. | |
25 | 00816784020963 | 2015-0222 | ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 1000 | ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 1000 | LGC CLINICAL DIAGNOSTICS, INC. | |
26 | 00816784020918 | 0505-0133 | 0505-0133 | AccuPlex™ SARS-CoV-2 Molecular Controls kit (Positive and Negative member-5 X 1.5 ml) | AccuPlex™ SARS-CoV-2 Molecular Controls kit | LGC CLINICAL DIAGNOSTICS, INC. |
27 | 00816784020802 | 2020-0093 | 2020-0093 | ACCURUN 315 Series 500 HIV-1 RNA 5 x 1.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
28 | 00816784020710 | 2035-0007 | 2035-0007 | ACCURUN 803 NUCLEIC ACID HIV, HCV, HBV 10 x 1.2 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
29 | 00816784020628 | 2020-0105 | 2020-0105 | ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 4.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
30 | 00816784020611 | 2020-0104 | 2020-0104 | ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 1.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
31 | 00816784020604 | 2020-0098 | 2020-0098 | ACCURUN 325 Series 700 HBV DNA 5 x 4.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
32 | 00816784020598 | 2020-0096 | 2020-0096 | ACCURUN 325 Series 200 HBV DNA 5 x 4.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
33 | 00816784020581 | 2020-0095 | 2020-0095 | ACCURUN 325 Series 370 HBV DNA Positive Control 5 x 0.6 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
34 | 00816784020574 | 2020-0092 | 2020-0092 | ACCURUN 315 Series 400 HIV-1 RNA 5 x 1.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
35 | 00816784020567 | 2020-0090 | 2020-0090 | ACCURUN 315 Series 200 HIV-1 RNA 5 x 1.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
36 | 00816784020550 | 2020-0087 | 2020-0087 | ACCURUN 315 Series 150 HIV-1 RNA 10 x 1.2 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
37 | 00816784020536 | 2020-0085 | 2020-0085 | ACCURUN 305 Series 400 HCV RNA 5 x 4.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
38 | 00816784020529 | 2020-0083 | 2020-0083 | ACCURUN 305 Series 300 HCV RNA 5 x 1.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
39 | 00816784020512 | 2020-0080 | 2020-0080 | ACCURUN 305 Series 100 HCV RNA 5 x 1.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
40 | 00816784020505 | 2020-0078 | 2020-0078 | ACCURUN 305 Series 150 HCV RNA Positive Control 10 x 1.2 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
41 | 00816776020001 | 186002891 | 186002891 | Waters® MassTrak™ Immunosuppressants Kit | MassTrak™ | WATERS TECHNOLOGIES CORPORATION |
42 | 00816703021927 | MS-76016 | Glucometer Test Solution (Normal, high) | MedSource Glucometer Test Solution (Normal, high) | MEDSOURCE INTERNATIONAL LLC | |
43 | 00816703021910 | MS-76012 | Glucometer Test Strips, DS-A | MedSource Glucometer Test Strips, DS-A | MEDSOURCE INTERNATIONAL LLC | |
44 | 00816703021231 | MS-76010 | Glucose Meter, DS-A | MedSource Glucose Meter, DS-A | MEDSOURCE INTERNATIONAL LLC | |
45 | 00816467020167 | PSA Controls | 25000003 | Two levels of controls for the following assays: TPSA, FPSAFPSA is not available Two levels of controls for the following assays: TPSA, FPSAFPSA is not available in the US. | Control Kit - PSA | QUALIGEN INC. |
46 | 00816467020143 | Vit. D Verifier | 25000064, 25000074 | Method Verification Kit - Vitamin D | QUALIGEN INC. | |
47 | 00816467020075 | TPSA Verifier | 25000017 | Method Verification Kit - PSA | QUALIGEN INC. | |
48 | 00816426021679 | K180C-2M | K180C-2M | For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for C-reactive protein (CRP). | K-ASSAY® hsCRP Control | KAMIYA BIOMEDICAL COMPANY, LLC |
49 | 00816426021389 | K94C-4M | K94C-4M | For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for Total IgE. | K-ASSAY® Total IgE Control | KAMIYA BIOMEDICAL COMPANY, LLC |
50 | 00816426021372 | K94C-2M | K94C-2M | For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for Total IgE. | K-ASSAY® Total IgE Control | KAMIYA BIOMEDICAL COMPANY, LLC |