Other products from "PHADIA AB"
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
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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