No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10845357043631 | HE0062-DN | HE0062-DN | Helix Elite™ Molecular Standards SARS-CoV-2 Process Control (Pellet) | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
2 | 10845357043556 | HE0063S | HE0063S | Helix Elite™ Molecular Standards SARS-CoV-2 Process Control (Swab) | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
3 | 10845357043488 | HE0062S | HE0062S | Helix Elite™ Molecular Standards SARS-CoV-2 Process Control (Pellet) | OHQ | Multi-Analyte Controls Unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
4 | 10845357043464 | HE0061S | HE0061S | Helix Elite™ Molecular Standards SARS-CoV-2 Synthetic RNA Pool (N/E/RdRp/S Gene Targets) | OHQ | Multi-Analyte Controls Unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
5 | 10845357043457 | HE0060S | HE0060S | Helix Elite™ Molecular Standards SARS-CoV-2 Synthetic RNA (N Gene Targets) | OHQ | Multi-Analyte Controls Unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
6 | 10845357041996 | HE0048S | HE0048S | Helix Elite™ Molecular Standards Human papillomavirus 18 Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
7 | 10845357041989 | HE0047S | HE0047S | Helix Elite™ Molecular Standards Treponema pallidum Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
8 | 10845357041972 | HE0046S | HE0046S | Helix Elite™ Molecular Standards Human papillomavirus 16 Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
9 | 10845357041965 | HE0025S | HE0025S | Helix Elite™ Molecular Standards Cyclospora cayetanensis Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
10 | 10845357041880 | HE0016S | HE0016S | Helix Elite™ Molecular Standards Eastern Equine Encephalitis Virus Synthetic RNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
11 | 10845357041873 | HE0015S | HE0015S | Helix Elite™ Molecular Standards Dientamoeba fragilis Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
12 | 10845357041866 | HE0014S | HE0014S | Helix Elite™ Molecular Standards West Nile Virus Synthetic RNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
13 | 10845357041859 | HE0013S | HE0013S | Helix Elite™ Molecular Standards Norovirus GI.1 Synthetic RNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
14 | 10845357041842 | HE0012S | HE0012S | Helix Elite™ Molecular Standards Norovirus GII.4 Synthetic RNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
15 | 10845357041835 | HE0011S | HE0011S | Helix Elite™ Molecular Standards Plasmodium malariae Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
16 | 10845357041828 | HE0010S | HE0010S | Helix Elite™ Molecular Standards Plasmodium ovale Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
17 | 10845357041811 | HE0009S | HE0009S | Helix Elite™ Molecular Standards Plasmodium vivax Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
18 | 10845357041804 | HE0008S | HE0008S | Helix Elite™ Molecular Standards Plasmodium falciparum Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
19 | 10845357041798 | HE0007S | HE0007S | Helix Elite™ Molecular Standards Entamoeba dispar Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
20 | 10845357041781 | HE0006S | HE0006S | Helix Elite™ Molecular Standards Entamoeba histolytica Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
21 | 10845357041774 | HE0005S | HE0005S | Helix Elite™ Molecular Standards Giardia lamblia Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
22 | 10845357041767 | HE0004S | HE0004S | Helix Elite™ Molecular Standards Encephalitozoon intestinalis Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
23 | 10845357041750 | HE0003S | HE0003S | Helix Elite™ Molecular Standards Enterocytozoon bieneusi Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
24 | 10845357041743 | HE0002S | HE0002S | Helix Elite™ Molecular Standards Cryptosporidium parvum Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
25 | 10845357041736 | HE0001S | HE0001S | Helix Elite™ Molecular Standards Cryptosporidium hominis Synthetic DNA | OHQ | Multi-analyte controls unassayed | 1 | Helix Elite™ Molecular Standards: Synthetic Standard |
26 | 10634853001418 | VV-01 | VV-01 | Vaginitis Validation Panel | OHQ | Multi-analyte controls unassayed | 1 | Tri-Valent™ Swab |
27 | 10634853001401 | VP-03 | VP-03 | Trichomonas Verification Set | OHQ | Multi-analyte controls unassayed | 1 | Tri-Valent™ Swab |
28 | 10634853001395 | TVS-02 | TVS-02 | Tri-Valent Negative Control Swab | OHQ | Multi-analyte controls unassayed | 1 | Tri-Valent™ Swab |
29 | 10634853001388 | TVS-01 | TVS-01 | Tri-Valent Positive Control Swab | OHQ | Multi-analyte controls unassayed | 1 | Tri-Valent™ Swab |
30 | 10634853001364 | CV-01 | CV-01 | Vaginitis Calibration Panel | JIT | Calibrator, secondary | 2 | Tri-Valent™ Swab |
31 | 10634853000510 | 100115 | 100115 | India Ink Kit | JTS | Stains, microbiologic | 1 | India Ink |
32 | 10634853000503 | 100114 | 100114 | India Ink | JTS | Stains, microbiologic | 1 | India Ink |
33 | 10634853000497 | 100112 | 100112 | India Ink, Negative Control | JTS | Stains, microbiologic | 1 | India Ink |
34 | 10634853000480 | 100111 | 100111 | India Ink, Positive Control | JTS | Stains, microbiologic | 1 | India Ink |
35 | 10845357043020 | 01258L | 01258L | LYFO DISK™ B. fulva ATCC 24474™ | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
36 | 10845357043099 | 01273L | 01273L | LYFO DISK™ N. gonorrhoeae CDC P681E | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
37 | 10845357042825 | 01272L | 01272L | LYFO DISK™ L. johnsonii ATCC 11506™ | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
38 | 10845357042658 | 01270L | 01270L | LYFO DISK™ B. multivorans ATCC BAA-247™ | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
39 | 10845357042627 | 01269L | 01269L | LYFO DISK™ B. cenocepacia ATCC BAA-245™ | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
40 | 10845357042429 | 01266L | 01266L | LYFO DISK™ A. baumannii NCTC 13304 | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
41 | 10845357041705 | 01265L | 01265L | LYFO DISK™ E. coli NCTC 13353 | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
42 | 10845357041699 | 01264L | 01264L | LYFO DISK™ A. terreus ATCC 1012™ | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
43 | 10845357041286 | 01263L | 01263L | LYFO DISK™ K. pneumoniae ATCC BAA-2814™ | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
44 | 10845357041279 | 01262L | 01262L | LYFO DISK™ L. brevis ATCC 14869™ | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
45 | 10845357041019 | 01261L | 01261L | LYFO DISK™ E. coli ATCC BAA-1429™ | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
46 | 10845357040982 | 01260L | 01260L | LYFO DISK™ E. faecium ATCC 8459™ | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
47 | 10845357040944 | 01259L | 01259L | LYFO DISK™ E. coli CDC AR-0346 | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
48 | 10845357040418 | 01244L | 01244L | LYFO DISK™ E. coli NCTC 13846 | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
49 | 10845357040722 | 01256L | 01256L | LYFO DISK™ C. auris CDC B11903 | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
50 | 10845357040692 | 01257L | 01257L | LYFO DISK™ S. Nottingham NCTC 7832 | JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | 1 | LYFO DISK™ |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 03610520530092 | 12000531 | 12000531 | Amplichek I MiniPak (An assayed nucleic acid control.) | Amplichek | BIO-RAD LABORATORIES, INC. |
2 | 03610520530085 | 12000530 | 12000530 | Amplichek I Level 3 (An assayed nucleic acid control.) | Amplichek | BIO-RAD LABORATORIES, INC. |
3 | 03610520530078 | 12000529 | 12000529 | Amplichek I Level 2 (An assayed nucleic acid control.) | Amplichek | BIO-RAD LABORATORIES, INC. |
4 | 03610520530061 | 12000528 | 12000528 | Amplichek I Level 1 (An assayed nucleic acid control.) | Amplichek | BIO-RAD LABORATORIES, INC. |
5 | 03610520530054 | 12000527 | 12000527 | Amplichek I Negative (An assayed nucleic acid control.) | Amplichek | BIO-RAD LABORATORIES, INC. |
6 | 01220000260252 | NATtrol™ Candida/TV Positive Control | NATCTVPOS-BD | NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an as NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol Candida/TV Positive Control is a qualitative control containing intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert. | NATtrol™ | ZEPTOMETRIX CORPORATION |
7 | 01220000260245 | NATtrol™ BV Negative Control | NATBVNEG-BD | NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed qua NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for the BD MAX™ System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert. | NATtrol™ | ZEPTOMETRIX CORPORATION |
8 | 01220000260238 | NATtrol™ BV Positive Control | NATBVPOS-BD | NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed qua NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for the BD MAX™ System. NATtrol™ BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert. | NATtrol™ | ZEPTOMETRIX CORPORATION |
9 | 00852720008114 | v.00 | M441 | External quality controls to monitor the performance of in vitro laboratory nucl External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP2.1/ RP2.1plus assay on the FilmArray 2.0/Torch systems. | BioFire RP2.1/RP2.1plus Control Panel M441 | MMQCI |
10 | 00852720008077 | v.00 | M416 | External quality controls to monitor the performance of in vitro laboratory nucl External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the BioFire Blood Culture Identification 2 (BCID2) Panel on the FilmArray systems. | FilmArray BCID2 Control Panel M416 | MMQCI |
11 | 00852720008053 | v.00 | M290 | External quality controls to monitor the performance of in vitro laboratory nucl External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray® NGDS Warrior Panel performed on FilmArray systems. | FilmArray Warrior Control Panel M290 | MMQCI |
12 | 00852720008046 | v.00 | M265 | External quality controls to monitor the performance of in vitro laboratory nucl External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP EZ assay on the FilmArray systems. | FilmArray RP EZ Control Panel M265 | MMQCI |
13 | 00852720008039 | v.00 | M315 | External quality controls to monitor the performance of in vitro laboratory nucl External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP2 and RP2plus assay on the FilmArray 2.0/Torch systems. | FilmArray RP2/RP2plus Control Panel | MMQCI |
14 | 00852720008022 | v.00 | M340 | External quality controls to monitor the performance of in vitro laboratory nucl External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray Pneumonia Panel or Pneumonia Panel plus assay on the FilmArray systems. | FilmArray Pneumonia/Pneumoniaplus Control | MMQCI |
15 | 00851458005259 | DFA2-ASY-0006 | DFA2-ASY-0006 | BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel - IVD Reagent Ex BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel - IVD Reagent External Control Kit | BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel | BIOFIRE DEFENSE, LLC |
16 | 00847661005995 | 12000578 | 12000578 | Amplichek II Level 3 MiniPak (A nucleic acid control.) | Amplichek | BIO-RAD LABORATORIES, INC. |
17 | 00847661005988 | 12000577 | 12000577 | Amplichek II Level 2 MiniPak (A nucleic acid control.) | Amplichek | BIO-RAD LABORATORIES, INC. |
18 | 00847661005971 | 12000576 | 12000576 | Amplichek II Level 1 MiniPak (A nucleic acid control.) | Amplichek | BIO-RAD LABORATORIES, INC. |
19 | 00847661005964 | 12000575 | 12000575 | Amplichek II Negative MiniPak (A nucleic acid control.) | Amplichek | BIO-RAD LABORATORIES, INC. |
20 | 00847661005957 | 12000204 | 12000204 | Amplichek II Level 3 (A nucleic acid control.) | Amplichek | BIO-RAD LABORATORIES, INC. |
21 | 00847661005940 | 12000203 | 12000203 | Amplichek II Level 2 (A nucleic acid control.) | Amplichek | BIO-RAD LABORATORIES, INC. |
22 | 00847661005933 | 12000202 | 12000202 | Amplichek II Level 1 (A nucleic acid control.) | Amplichek | BIO-RAD LABORATORIES, INC. |
23 | 00847661005926 | 12000201 | 12000201 | Amplichek II Negative (A nucleic acid control.) | Amplichek | BIO-RAD LABORATORIES, INC. |
24 | 00844509002338 | 250065 | 250065 | MDx-Chex for BCID2 is intended for use as an external positive and negative assa MDx-Chex for BCID2 is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast, Gram positive and Gram negative bacteria, as well as associated antimicrobial resistance genes, by the BioFire® FilmArray® Blood Culture Identification 2 (BCID2) Panel on FilmArray® systems. Control 1 - GN: Gram negative bacteria: Acinetobacter colcoaceticus-baumannii complex, Bacteroides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenza, Neisseria meningitides, Pseudomonas aeruginosa, Stenotrophomonas maltophilia; antimicrobial resistance genes: KPC, CTX-M, IMP, NDM, OXA-48-like, VIM, mcr-1. Control 2 - GPY: Gram positive bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunesis, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes; yeast: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Cryptococcus neoformans/gatti; antimicrobial resistance genes: mecA/C and MREJ, vanA/B. This product is not intended to replace manufacturer controls provided with the device. | MDx-Chex for BCID2 | STRECK, INC. |
25 | 70845357041394 | 8204 BD MAX™ Enteric Parasite Control Panel | 8204 | BD MAX™ Enteric Parasite Control Panel | QC Sets and Panels: Helix Elite™ | MICROBIOLOGICS INC. |
26 | 70845357041370 | 8200 Cepheid Xpert® C. difficile/Epi Control Panel | 8200 | Cepheid Xpert® C. difficile/Epi Control Panel | QC Sets and Panels: Helix Elite™ | MICROBIOLOGICS INC. |
27 | 70845357041240 | 8199 Cepheid Xpert® Respiratory Control Panel | 8199 | Cepheid Xpert® Respiratory Control Panel | QC Sets and Panels: Helix Elite™ | MICROBIOLOGICS INC. |
28 | 70845357041233 | 8196 Cepheid Xpert® SA Nasal Complete Control Panel | 8196 | Cepheid Xpert® SA Nasal Complete Control Panel | QC Sets and Panels: Helix Elite™ | MICROBIOLOGICS INC. |
29 | 70845357041226 | 8195 Cepheid Xpert® MRSA NxG Control Panel | 8195 | Cepheid Xpert® MRSA NxG Control Panel | QC Sets and Panels: Helix Elite™ | MICROBIOLOGICS INC. |
30 | 70845357041219 | 8194 Cepheid Xpert® GBS LB Control Panel | 8194 | Cepheid Xpert® GBS LB Control Panel | QC Sets and Panels: Helix Elite™ | MICROBIOLOGICS INC. |
31 | 70845357041189 | 8188 Cepheid Xpert® CT/NG Control Panel | 8188 | Cepheid Xpert® CT/NG Control Panel | QC Sets and Panels: Helix Elite™ | MICROBIOLOGICS INC. |
32 | 70845357041097 | 8202 BD MAX™ Enteric Parasite 20-Day QC Panel | 8202 | BD MAX™ Enteric Parasite 20-Day QC Panel | QC Sets and Panels: Helix Elite™ | MICROBIOLOGICS INC. |
33 | 70845357041080 | 8193 BD MAX™ CT/GC/TV 20-Day QC Panel | 8193 | BD MAX™ CT/GC/TV 20-Day QC Panel | QC Sets and Panels: Helix Elite™ | MICROBIOLOGICS INC. |
34 | 15420045512054 | BV CONTROLS, APTIMA, 100T, IVD | PRD-05187 | APTIMA | HOLOGIC, INC. | |
35 | 15420045512047 | BV CALIBRATOR, APTIMA, 100T, IVD | PRD-05188 | APTIMA | HOLOGIC, INC. | |
36 | 15420045512030 | BV ASSAY, APTIMA, 100T, IVD | PRD-05186 | APTIMA | HOLOGIC, INC. | |
37 | 15420045512023 | BV ASSAY, APTIMA, 100T, IVD | PRD-05186 | APTIMA | HOLOGIC, INC. |