| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 07333066022307 | 34-2317-93 | 34-2317-93 | Phadia Maintenance Solution Small | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Phadia Maintenance Solution Small |
| 2 | 07333066019994 | 83-0008-01 | 83-0008-01 | EliA APS Positive Control 250 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | EliA APS Positive Control 250 |
| 3 | 07333066019987 | 83-0007-91 | 83-0007-91 | EliA APS Positive Control 100 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | EliA APS Positive Control 100 |
| 4 | 07333066019970 | 83-0006-71 | 83-0006-71 | EliA Celiac Positive Control 250 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | EliA Celiac Positive Control 250 |
| 5 | 07333066019963 | 34-2341-31 | 34-2341-31 | ImmunoCAP Specific IgE Control H | DHB | System, test, radioallergosorbent (rast) immunological | 2 | ImmunoCAP Specific IgE Control H |
| 6 | 07333066019949 | 34-2341-11 | 34-2341-11 | ImmunoCAP Specific IgE Control L | DHB | System, test, radioallergosorbent (rast) immunological | 2 | ImmunoCAP Specific IgE Control L |
| 7 | 07333066019857 | 34-2325-31 | 34-2325-31 | ImmunoCAP Autoimmunity Specific IgG Sample Diluent | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Autoimmunity Specific IgG Sample Diluent |
| 8 | 07333066019840 | 34-2316-11 | 34-2316-11 | ImmunoCAP Autoimmunity Specific IgG Sample Diluent | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Autoimmunity Specific IgG Sample Diluent |
| 9 | 07333066019826 | 34-2294-41 | 34-2294-41 | ImmunoCAP Specific IgG Conjugate | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Specific IgG Conjugate |
| 10 | 07333066019628 | 10-9414-01 | 10-9414-01 | Contains 2 vials of each IgG antibodies level (N: normal; L: low; H: high) for t Contains 2 vials of each IgG antibodies level (N: normal; L: low; H: high) for the ImmunoCAP Thyroid Peroxidase method. | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Thyroid Peroxidase IgG Antibodies Control NLH |
| 11 | 07333066014807 | DECC055390 | DECC055390 | EliA GliadinDP IgG Well | MST | Antibodies, gliadin | 2 | EliA GliadinDP IgG Well |
| 12 | 07333066017549 | 14-6016-01 | 14-6016-01 | ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee | PUW | System, test, radioallergosorbent (Rast) immunological, exempt allergens | 2 | ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee |
| 13 | 07333066017532 | 14-6015-01 | 14-6015-01 | ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee | PUW | System, test, radioallergosorbent (Rast) immunological, exempt allergens | 2 | ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee |
| 14 | 07333066014852 | DECC056490 | DECC056490 | EliA M2 Well | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | EliA M2 Well |
| 15 | 07333066014746 | DECC055310 | DECC055310 | EliA ß2-Glycoprotein I IgA Well | MSV | System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | EliA ß2-Glycoprotein I IgA Well |
| 16 | 07333066014692 | DECC055200 | DECC055200 | EliA Gliadin IgG Well | MST | Antibodies, gliadin | 2 | EliA Gliadin IgG Well |
| 17 | 07333066013138 | 83-0008-51 | 83-0008-51 | EliA IgM Conjugate 200 | DHR | SYSTEM, TEST, RHEUMATOID FACTOR | 2 | EliA IgM Conjugate 200 |
| 18 | 07333066013077 | 83-0007-21 | 83-0007-21 | EliA Celiac Positive Control 100 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | EliA Celiac Positive Control 100 |
| 19 | 07333066013060 | 83-0007-11 | 83-0007-11 | EliA CCP Positive Control 100 | NHX | ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) | 2 | EliA CCP Positive Control 100 |
| 20 | 07333066012841 | 83-0003-41 | 83-0003-41 | EliA IgA Curve Control Strip | MVM | Autoantibodies, endomysial(tissue transglutaminase) | 2 | EliA IgA Curve Control Strip |
| 21 | 07333066012780 | 83-0002-81 | 83-0002-81 | EliA IgA Conjugate | MVM | Autoantibodies, endomysial(tissue transglutaminase) | EliA IgA Conjugate | |
| 22 | 07333066011615 | 34-2273-31 | 34-2273-31 | ImmunoCAP Specific IgG Curve Control Strip | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Specific IgG Curve Control Strip |
| 23 | 07333066010496 | 14-5341-01 | 14-5341-01 | ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut |
| 24 | 07333066009902 | 14-5304-10 | 14-5304-10 | ImmunoCAP Antigen RGm24, Stachybotrys atra | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Antigen RGm24, Stachybotrys atra |
| 25 | 07333066009841 | 14-5301-10 | 14-5301-10 | ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST |
| 26 | 07333066009193 | 14-5254-10 | 14-5254-10 | ImmunoCAP Allergen f335, Lupine seed | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen f335, Lupine seed |
| 27 | 07333066009094 | 14-5249-10 | 14-5249-10 | ImmunoCAP Rare Allergen Rf332, Mint | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rf332, Mint |
| 28 | 07333066008424 | 14-5209-10 | 14-5209-10 | ImmunoCAP Allergen Rf313, Anchovy | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf313, Anchovy |
| 29 | 07333066008363 | 14-5206-10 | 14-5206-10 | ImmunoCAP Allergen Rfx21, Fruits | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rfx21, Fruits |
| 30 | 07333066008288 | 14-5202-10 | 14-5202-10 | ImmunoCAP Allergen Rm208, Chaetomium globosum | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rm208, Chaetomium globosum |
| 31 | 07333066008059 | 14-5189-10 | 14-5189-10 | ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid |
| 32 | 07333066007953 | 14-5183-10 | 14-5183-10 | ImmunoCAP Allergen Rtx10, Tree pollen | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rtx10, Tree pollen |
| 33 | 07333066007496 | 14-5139-10 | 14-5139-10 | ImmunoCAP Rare Allergen Rf298, Tragacanth | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rf298, Tragacanth |
| 34 | 07333066006925 | 14-5086-10 | 14-5086-10 | ImmunoCAP Allergen Rf212, Mushroom (champignon) | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf212, Mushroom (champignon) |
| 35 | 07333066006642 | 14-5065-10 | 14-5065-10 | ImmunoCAP Allergen Rf221, Coffee | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf221, Coffee |
| 36 | 07333066006628 | 14-5064-10 | 14-5064-10 | ImmunoCAP Allergen Rf268, Clove | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf268, Clove |
| 37 | 07333066006574 | 14-5060-10 | 14-5060-10 | ImmunoCAP Allergen Rf291, Cauliflower | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf291, Cauliflower |
| 38 | 07333066006352 | 14-5044-10 | 14-5044-10 | ImmunoCAP Allergen Rf271, Anise | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf271, Anise |
| 39 | 07333066006147 | 14-5026-10 | 14-5026-10 | ImmunoCAP Allergen wx209, Ambrosia sp. | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen wx209, Ambrosia sp. |
| 40 | 07333066005768 | 14-4990-01 | 14-4990-01 | ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy |
| 41 | 07333066005713 | 14-4983-01 | 14-4983-01 | ImmunoCAP Allergen w233, Allergen component nArt v 3 LTP, Mugwort | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen w233, Allergen component nArt v 3 LTP, Mugwort |
| 42 | 07333066005638 | 14-4972-01 | 14-4972-01 | ImmunoCAP Allergen g216, Allergen component nCyn d 1 Bermuda grass | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen g216, Allergen component nCyn d 1 Bermuda grass |
| 43 | 07333066005539 | 14-4963-01 | 14-4963-01 | ImmunoCAP Allergen f422, Allergen component rAra h 1 Peanut | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f422, Allergen component rAra h 1 Peanut |
| 44 | 07333066005508 | 14-4960-01 | 14-4960-01 | ImmunoCAP Allergen f419, Allergen component rPru p 1 PR-10, Peach | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f419, Allergen component rPru p 1 PR-10, Peach |
| 45 | 07333066005386 | 14-4950-10 | 14-4950-10 | ImmunoCAP Allergen Rw23, Yellow dock | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rw23, Yellow dock |
| 46 | 07333066004556 | 14-4843-01 | 14-4843-01 | ImmunoCAP Allergen f299, Sweet chestnut | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f299, Sweet chestnut |
| 47 | 07333066004488 | 14-4836-01 | 14-4836-01 | ImmunoCAP Allergen f203, Pistachio | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f203, Pistachio |
| 48 | 07333066004327 | 14-4820-01 | 14-4820-01 | ImmunoCAP Allergen f207, Clam | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f207, Clam |
| 49 | 07333066004303 | 14-4818-01 | 14-4818-01 | ImmunoCAP Allergen f284, Turkey meat | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f284, Turkey meat |
| 50 | 07333066003801 | 14-4434-01 | 14-4434-01 | ImmunoCAP Allergen f254, Plaice | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f254, Plaice |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 03610522207930 | 200505 | 200505 | VIROCLEAR SARS-CoV-2 (An unassayed (human) serology control.) | VIROCLEAR | BIO-RAD LABORATORIES, INC. |
| 2 | 03610522207923 | 200500 | 200500 | VIROCLEAR SARS-CoV-2 (An unassayed (human) serology control.) | VIROCLEAR | BIO-RAD LABORATORIES, INC. |
| 3 | 03610522207893 | 200305C | 200305C | VIROTROL SARS-CoV-2 (An unassayed (human) serology control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 4 | 03610522207886 | 200305B | 200305B | VIROTROL SARS-CoV-2 (An unassayed (human) serology control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 5 | 03610522207879 | 200305A | 200305A | VIROTROL SARS-CoV-2 (An unassayed (human) serology control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 6 | 03610522207862 | 200300C | 200300C | VIROTROL SARS-CoV-2 (An unassayed (human) serology control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 7 | 03610522207855 | 200300B | 200300B | VIROTROL SARS-CoV-2 (An unassayed (human) serology control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 8 | 03610522207848 | 200300A | 200300A | VIROTROL SARS-CoV-2 (An unassayed (human) serology control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 9 | 03610520540718 | 00117A | 00117A | VIROTROL ToRCH-M (An unassayed (human) serology control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 10 | 03610520540374 | 12000953 | 12000953 | Liquichek Netherlands Unassayed Chemistry Plus Control Level 3 ( A human serum c Liquichek Netherlands Unassayed Chemistry Plus Control Level 3 ( A human serum chemistry and protein control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
| 11 | 03610520540367 | 12000952 | 12000952 | Liquichek Netherlands Unassayed Chemistry Plus Control Level 2 ( A human serum c Liquichek Netherlands Unassayed Chemistry Plus Control Level 2 ( A human serum chemistry and protein control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
| 12 | 03610520540350 | 12000951 | 12000951 | Liquichek Netherlands Unassayed Chemistry Plus Control Level 1 ( A human serum c Liquichek Netherlands Unassayed Chemistry Plus Control Level 1 ( A human serum chemistry and protein control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
| 13 | 03610520530146 | 12000539 | 12000539 | VIROTROL PLUS-R (An unassayed (human) serology control) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 14 | 03610520530139 | 12000538 | 12000538 | VIROTROL PLUS-R (An unassayed (human) serology control) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 15 | 03610520105900 | 00113X | 00113X | VIROTROL HIV-1 gO (An unassayed (human) serology control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 16 | 03610520105719 | 00113 | 00113 | VIROTROL HIV-1 gO (An unassayed (human) serology control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 17 | 03573026121631 | 30706 | Automated test for use on the VIDAS® system to detect abnormal operation of the Automated test for use on the VIDAS® system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. | VIDAS® QCV | BIOMERIEUX SA | |
| 18 | 01220000260313 | NATtrol™ Vaginal Bundle | NATV-BU1 | NATtrol™ Vaginal Bundle contains qualitative in vitro diagnostic controls, NATtr NATtrol™ Vaginal Bundle contains qualitative in vitro diagnostic controls, NATtrol Vaginal Positive Control (NATVPOS-6C) DI number 01220000260290, and NATtrol Vaginal Negative Control (NATVNEG-6C) DI number 01220000260306, which are intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis for the evaluation of test performance. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 19 | 01220000260306 | NATtrol™ Vaginal Negative Control | NATVNEG-6C | NATtrol™ Vaginal Negative Control (NATVNEG-6C) is a qualitative in vitro diagnos NATtrol™ Vaginal Negative Control (NATVNEG-6C) is a qualitative in vitro diagnostic control intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis for the evaluation of test performance. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 20 | 01220000260290 | NATtrol™ Vaginal Positive Control | NATVPOS-6C | NATtrol™ Vaginal Positive Control (NATVPOS-6C) is a qualitative in vitro diagnos NATtrol™ Vaginal Positive Control (NATVPOS-6C) is a qualitative in vitro diagnostic control intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis for the evaluation of test performance. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 21 | 01220000260283 | NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Control | NATCTNGNEG-6MC | NATCTNGNEG-6MC is a qualitative in vitro diagnostic external run control intende NATCTNGNEG-6MC is a qualitative in vitro diagnostic external run control intended to be used with molecular assays. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 22 | 01220000260276 | NATtrol™ Neisseria gonorrhoeae (NG) Positive Control | NATNG-6MC | NATNG-6MC is a qualitative in vitro diagnostic external run control intended to NATNG-6MC is a qualitative in vitro diagnostic external run control intended to be used with molecular assays. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 23 | 01220000260269 | NATtrol™ Chlamydia trachomatis (CT) Positive Control | NATCT(434)-6MC | NATCT(434)-6MC is a qualitative in vitro diagnostic external run control intende NATCT(434)-6MC is a qualitative in vitro diagnostic external run control intended to be used with molecular assays. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 24 | 01220000260221 | NATtrol™ Staphylococcus aureus Positive Control | NATMSSA-6MC-IVD | The NATtrol™ Staphylococcus aureus (SA) Positive Control is an unassayed in vitr The NATtrol™ Staphylococcus aureus (SA) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ SA Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 25 | 01220000260214 | NATtrol™ Methicillin-Resistant Staphylococcus aureus/Staphylococcus aureus | NATMSSE-6MC-IVD | The Methicillin-Resistant Staphylococcus aureus/Staphylococcus aureus (MRSA/SA) The Methicillin-Resistant Staphylococcus aureus/Staphylococcus aureus (MRSA/SA) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ MRSA/SA Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 26 | 01220000260207 | NATtrol™ Methicillin-Resistant Staphylococcus aureus Positive Control | NATMRSA-6MC-IVD | The NATtrol™ Methicillin-Resistant Staphylococcus aureus (MRSA) Positive Control The NATtrol™ Methicillin-Resistant Staphylococcus aureus (MRSA) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ MRSA Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 27 | 01220000260191 | NATtrol™ Trichomonas vaginalis Negative Control | NATTVNEG-6MC-IVD | The NATtrol™ Trichomonas vaginalis (T. vaginalis) Negative Control is an unassay The NATtrol™ Trichomonas vaginalis (T. vaginalis) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ T. vaginalis Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 28 | 01220000260177 | NATtrol™ Enterovirus Negative Control | NATEVNEG-6MC-IVD | The NATtrol™ Enterovirus (EV) Negative Control is an unassayed in vitro diagnost The NATtrol™ Enterovirus (EV) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ EV Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 29 | 01220000260160 | NATtrol™ Enterovirus Positive Control | NATEVPOS-6MC-IVD | The NATtrol™ Enterovirus (EV) Positive Control is an unassayed in vitro diagnost The NATtrol™ Enterovirus (EV) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ EV Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 30 | 01220000260153 | NATtrol™ Group B Streptococci Negative Control | NATLAC-6MC-IVD | The NATtrol™ Group B Streptococcus (GBS) Negative Control is an unassayed in vit The NATtrol™ Group B Streptococcus (GBS) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ GBS Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 31 | 01220000260146 | NATtrol™ Group B Streptococci Positive Control | NATSAG-6MC-IVD | The NATtrol™ Group B Streptococcus (GBS) Positive Control is an unassayed in vit The NATtrol™ Group B Streptococcus (GBS) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ GBS Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 32 | 01220000260139 | NATtrol™ Norovirus Negative Control | NATROTA-6MC-IVD | The NATtrol™ Norovirus Negative Control is an unassayed in vitro diagnostic exte The NATtrol™ Norovirus Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Norovirus Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 33 | 01220000260122 | NATtrol™ Norovirus GII Positive Control | NATNOVII-6MC-IVD | The NATtrol™ Norovirus GII Positive Control is an unassayed in vitro diagnostic The NATtrol™ Norovirus GII Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Norovirus GII Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 34 | 01220000260115 | NATtrol™ Norovirus GI Positive Control | NATNOVI-6MC-IVD | The NATtrol™ Norovirus GI Positive Control is an unassayed in vitro diagnostic e The NATtrol™ Norovirus GI Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Norovirus GI Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 35 | 01220000260108 | NATtrol™ Norovirus GI/GII Positive Control | NATNOV-6MC-IVD | The NATtrol™ Norovirus GI/GII Positive Control is an unassayed in vitro diagnost The NATtrol™ Norovirus GI/GII Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Norovirus GI/GII Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 36 | 01220000260092 | NATtrol™ RSV Positive Control | NATRSV-6C-IVD | The NATtrol™ RSV Positive Control is an unassayed in vitro diagnostic external r The NATtrol™ RSV Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ RSV Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 37 | 01220000260085 | NATtrol™ Influenza A/B Positive Control | NATFLUAB-6C-IVD | The NATtrol™ Influenza A/B Positive Control is an unassayed in vitro diagnostic The NATtrol™ Influenza A/B Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Influenza A/B Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 38 | 01220000260078 | NATtrol™ Influenza/RSV Negative Control | NATCXVA9-6C-IVD | The NATtrol™ Influenza/RSV Negative Control is an unassayed in vitro diagnostic The NATtrol™ Influenza/RSV Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Influenza/RSV Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 39 | 01220000260061 | NATtrol™ Clostridium difficile Negative Control | NATCSO-6MC-IVD | The NATtrol™ Clostridium difficile Negative Control is an unassayed in vitro dia The NATtrol™ Clostridium difficile Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Clostridium difficile Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 40 | 01220000260054 | NATtrol™ Clostridium difficile Positive Control | NATCDI-6MC-IVD | The NATtrol™ Clostridium difficile Positive Control is an unassayed in vitro dia The NATtrol™ Clostridium difficile Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Clostridium difficile Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 41 | 01220000260047 | NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae Negative Controls | NATCT/NGNEG-6MC-IVD | The NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Contro The NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ CT/NG Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 42 | 01220000260030 | NATtrol™ Neisseria gonorrhoeae Positive Controls | NATNG-6MC-IVD | The NATtrol™ Neisseria gonorrhoeae (NG) Positive Control is an unassayed in vitr The NATtrol™ Neisseria gonorrhoeae (NG) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Neisseria gonorrhoeae Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 43 | 01220000260023 | NATtrol™ Chlamydia trachomatis Positive Controls | NATCT(434)-6MC-IVD | NATtrol™ Chlamydia trachomatis (CT) Positive Control is an unassayed in vitro di NATtrol™ Chlamydia trachomatis (CT) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Chlamydia trachomatis (CT) Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 44 | 01220000260016 | NATtrol™ RP Multimarker Controls | MDZ001 | NATtrol™ RP Multimarker Controls (MDZ001) consist of in vitro diagnostic externa NATtrol™ RP Multimarker Controls (MDZ001) consist of in vitro diagnostic external run controls intended for use with qualitative molecular assays. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic error. NATtrol™ RP Multimarker Controls contain intact organisms and should be run in a manner identical to that used for clinical specimens.NATtrol™ RP Multimarker Controls are formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable. Each control pack contains 3 x 0.75 mL vials of RP Multimarker 1 and 3 x 0.75 mL vials of RP Multimarker 2. NATtrol™ RP Multimarker Controls are formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens. | NATtrol™ | ZEPTOMETRIX CORPORATION |
| 45 | EABA10090211 | 100-9021 | 100-9021 | BRT Verification Samples are human liquid serum samples used to verify analyte l BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range. | BRT Verification Samples with CRP | BIORESOURCE TECHNOLOGY |
| 46 | EABA10090111 | 100-9011 | 100-9011 | BRT Verification Samples are human liquid serum samples used to verify analyte l BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range. | BRT Verification Samples | BIORESOURCE TECHNOLOGY |
| 47 | 00884883007543 | 10027484 | MAS Infectious Negative Control | MICROGENICS CORPORATION | ||
| 48 | 00884883007536 | 10027483 | MAS Syphilis Positive Control | MICROGENICS CORPORATION | ||
| 49 | 00884883007529 | 10027482 | MAS anti-HBs Positive Control | MICROGENICS CORPORATION | ||
| 50 | 00884883007512 | 10027481 | MAS HIV p24 Positive Control | MICROGENICS CORPORATION |