No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10629009061255 | FRABP0125 | Intended for use in the quality control of coagulation assays in the borderline Intended for use in the quality control of coagulation assays in the borderline pathological range. | GGN | Plasma, Coagulation Control | VisuCon-F Frozen Abnormal Control Plasma | ||
2 | 10629009111103 | LCSAB201 | A pool of citrated human plasma collected from a minimum of 20 donors that has b A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The plasma is buffered with 0.05M HEPES buffer and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays (PT and APTT) in the highly abnormal range. | GGN | Plasma, Coagulation Control | VisuCon-L Coag Screen ABN2 Plasma | ||
3 | 10629009051058 | FRNCP0105 | Intended for use in the quality control of coagulation assays in the normal range. | GGN | Plasma, Coagulation Control | VisuCon-F Frozen Calibrator Plasma | ||
4 | 10629009101104 | LCSAB101 | A pool of citrated human plasma collected from a minimum of 20 donors that has b A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The plasma is buffered with 0.05M HEPES buffer and stabilizers, dispensed, and lyophilized. This plasma is used for the quality control of coagulation assays (PT and APTT) in the mid-level abnormal range. | GGN | Plasma, Coagulation Control | VisuCon-L Coag Screen ABN1 Plasma | ||
5 | 10629009020009 | FIX-AG | 96 Test enzyme immunoassay kit for the determination of FIX Antigen | GGP | Test, Qualitative And Quantitative Factor Deficiency | VisuLize Factor FIX Antigen Kit | ||
6 | 10629009010000 | FVIII-AG | 96 Test enzyme immunoassay kit for the determination of FVIII Antigen | GGP | Test, Qualitative And Quantitative Factor Deficiency | VisuLize Factor FVIII Antigen Kit | ||
7 | 10629009051256 | FRNCP0125 | Intended for use in the quality control of coagulation assays in the normal range. | GGN | Plasma, Coagulation Control | VisuCon-F Frozen Normal Control Plasma | ||
8 | 10629009031814 | LFGCP0181 | Assayed control plasma prepared from de-fibrinated human plasma intended for use Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. | GGN | Plasma, Coagulation Control | VisuCon-F Low Fibrinogen Control Plasma | ||
9 | 10629009061057 | FRABP0105 | Intended for use in the quality control of coagulation assays in the borderline Intended for use in the quality control of coagulation assays in the borderline pathological range. | GGN | Plasma, Coagulation Control | VisuCon-F Frozen Abnormal Control Plasma | ||
10 | 10629009031258 | LFGCP0125 | Assayed control plasma prepared from de-fibrinated human plasma intended for use Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. | GGN | Plasma, Coagulation Control | VisuCon-F Low Fibrinogen Control Plasma | ||
11 | 10629009031050 | LFGCP0105 | Assayed control plasma prepared from de-fibrinated human plasma intended for use Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. | GGN | Plasma, Coagulation Control | VisuCon-F Low Fibrinogen Control Plasma | ||
12 | 10629009081819 | FCSAB0181 | Intended for use in the quality control of quantitative coagulation assays, incl Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT), in the mid-level abnormal range. | GGN | Plasma, Coagulation Control | VisuCon-F Frozen Coag Screen ABN | ||
13 | 10629009081253 | FCSAB0125 | Intended for use in the quality control of quantitative coagulation assays, incl Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT), in the mid-level abnormal range. | GGN | Plasma, Coagulation Control | VisuCon-F Frozen Coag Screen ABN | ||
14 | 10629009084810 | FCSAB0481 | Intended for use in the quality control of quantitative coagulation assays, incl Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) in the mid-level abnormal range. | GGN | Plasma, Coagulation Control | VisuCon-F Frozen Coag Screen ABN | ||
15 | 10629009041059 | FRSP0105 | Intended for use in the calibration of coagulation and fibrinolysis assays. | JIX | Calibrator, Multi-Analyte Mixture | Visu-Cal F Frozen Calibrator Plasma | ||
16 | 10629009074811 | FCSN0481 | Intended for use in the quality control of quantitative coagulation assays, incl Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen, in the normal range. | GGN | Plasma, Coagulation Control | VisuCon-F Frozen Coag Screen N | ||
17 | 10629009071810 | FCSN0181 | Intended for the use in the quality control of quantitative coagulation assays, Intended for the use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen, in the normal range. | GGN | Plasma, Coagulation Control | VisuCon-F Frozen Coag Screen N | ||
18 | 10629009071254 | FCSN0125 | Intended for the use in quality control of quantitative coagulation assays, incl Intended for the use in quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen, in the normal range. | GGN | Plasma, Coagulation Control | VisuCon-F Frozen Coag Screen N | ||
19 | 10629009131101 | LYNCP01 | A pool of normal citrated human plasma collected from a minimum of 20 donors, bu A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays in the normal range, including fibrinogen, coagulation factors II, V, VII, VIII, IX, X XI and XII, ATIII activity, Protein C activity and Protein S activity. | GGN | Plasma, Coagulation Control | VisuCon-L(TM) Normal Control Plasma | ||
20 | 10629009121102 | LYABP01 | A pool of citrated normal human plasma collected from a minimum of 20 donors, an A pool of citrated normal human plasma collected from a minimum of 20 donors, and diluted to defined concentrations. Plasma is buffered with 0.05M HEPES and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays in the normal range, including fibrinogen, coagulation factors II, V, VII, VIII, IX, X XI and XII, ATIII activity, Protein C activity and Protein S activity. | GGN | Plasma, Coagulation Control | VisuCon-L(TM) Abnormal Control Plasma | ||
21 | 10629009091108 | LSCN01 | A pool of normal citrated human plasma collected from a minimum of 20 donors, bu A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES buffer and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays (PT, APTT and Fibinogen) in the normal range. | GGN | Plasma, Coagulation Control | VisuCon-L Coag Screen N Plasma | ||
22 | 10629009145016 | SAFXIII-IG-ASR-500 | The specific use of this ASR (Analyte Specific Reagent) will depend upon the end The specific use of this ASR (Analyte Specific Reagent) will depend upon the end user's application. | MVU | Reagents, Specific, Analyte | 1 | Sheep anti-human Factor XIII Analyte Specific Reagent | |
23 | 10629009140516 | SAFXIII-IG-ASR-5 | The specific use of this ASR (Analyte Specific Reagent) will depend upon the end The specific use of this ASR (Analyte Specific Reagent) will depend upon the end-user's application. | MVU | Reagents, Specific, Analyte | 1 | Sheep anti-human Factor XIII Analyte Specific Reagent |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00819704020180 | 2115 | 2115 | SEEKER™ LSD Reagent Kit - IDUA GAA | SEEKER™ | BAEBIES, INC. |
2 | 00819704020173 | 2111 | 2111 | The SEEKER™ LSD Reagent Kit - IDUA GAA GBA GLA is intended for quantitative meas The SEEKER™ LSD Reagent Kit - IDUA GAA GBA GLA is intended for quantitative measurement of the activity of α-L-iduronidase, α-D-glucosidase, β-glucocerebrosidase and α-D-galactosidase A from newborn dried blood spot specimens, using the SEEKER Instrument as an aid in screening newborns for Mucopolysaccharidosis Type I, Pompe, Gaucher and Fabry diseases. Reduced activity of these enzymes may be indicative of these lysosomal storage diseases. The enzymes measured using the SEEKER LSD Reagent Kit- IDUA GAA GBA GLA and their associated lysosomal storage diseases are listed below.α-L-iduronidase (IDUA) - Mucopolysaccharidosis Type I (MPS I)α-D-glucosidase (GAA) - Pompeβ-glucocerebrosidase (GBA) - Gaucherα-D-galactosidase (GLA) - Fabry | SEEKER™ | BAEBIES, INC. |
3 | 00819704020159 | 2131 | 2131 | SEEKER™ Calibrant D | SEEKER™ | BAEBIES, INC. |
4 | 00819704020142 | 2130 | 2130 | SEEKER™ Calibrant C | SEEKER™ | BAEBIES, INC. |
5 | 00819704020135 | 2129 | 2129 | SEEKER™ Calibrant B | SEEKER™ | BAEBIES, INC. |
6 | 00819704020128 | 2128 | 2128 | SEEKER™ Calibrant A | SEEKER™ | BAEBIES, INC. |
7 | 00817439020338 | CA1400 | CA1400 | For use as a calibrator in clinical chemistry assays. | Calibration Serum Level 2 | MEDTEST DX, INC. |
8 | 00817439020321 | CA1100 | CA1100 | For use as a Calibrator in clinical chemistry assays. Calibration Serum Level 1 For use as a Calibrator in clinical chemistry assays. Calibration Serum Level 1 is based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays on a wide range of automatic analyzers. Constituent concentrations are available at 1 level. | Calibrator Level 1 | MEDTEST DX, INC. |
9 | 00817302024517 | DT910 | DT910 | ISE SELECTIVITY CHECK | CAROLINA LIQUID CHEMISTRIES CORP.® ISE SELECTIVITY CHECK DT910 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
10 | 00817302024500 | DT909 | DT909 | ISE CALIBRATOR 2 | CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 2 DT909 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
11 | 00817302024494 | DT908 | DT908 | ISE CALIBRATOR 1 | CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 1 DT908 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
12 | 00817302023213 | DT88820 | DT88811 | Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820 | CAROLINA LIQUID CHEMISTRIES CORPORATION | |
13 | 00817302023176 | 28200 | 28200 | Serum Calibrator | CAROLINA LIQUID CHEMISTRIES CORP.® SERUM CAL KIT Product No. 28200 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
14 | 00817302022988 | DT313 | DT313 | CO2 (Carbon Dioxide) 4 x 300 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CO2 REAGENT PRODUCT NO. DT313 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
15 | 00817302022261 | 28200 | 28200 | Serum Calibrator | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 SERUM CAL KIT Product No. 28200 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
16 | 00817302022049 | AU-313 | AU-313 | CO2 (Carbon Dioxide) w/ cal 3 x 250 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT AU-313 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
17 | 00817302022032 | ST313 | ST313 | CO2 (Carbon Dioxide) w/ cal 4 x 200 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CO2 RGT KIT Product No. ST313 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
18 | 00817302022025 | BL313 | BL313 | CO2 (Carbon Dioxide) w/ cal 3 x 140 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT BL-313 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
19 | 00817302020472 | CC910 | CC910 | Cal Level 3 (BUN, CA, CREA, CO2, Electrolytes, GLU, PHOS) - CX3 Cal 6 x 25 mL | CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 3 CC910 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
20 | 00817302020465 | CC909 | CC909 | Cal Level 2 (BUN, CA, CREA, CO2, Electrolytes, GLU, PHOS) - CX3 Cal 6 x 25 mL | CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 2 CC909 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
21 | 00817302020458 | CC908 | CC908 | Cal Level 1 (BUN, CA, CREA, CO2, Electrolytes, GLU, PHOS) - CX3 Cal 6x 25 mL | CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 1 CC908 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
22 | 00817274022825 | MICS-10 | MICS-10 | Microprotein Standard (1 x 10 mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
23 | 00817274022818 | MICS-15 | MICS-15 | Microprotein Standard | JAS Diagnostics | DREW SCIENTIFIC, INC. |
24 | 00817274022207 | URIS-3U | URIC ACID STANDARD (1x 3mL) UV | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
25 | 00817274022108 | TRIS-3U | TRIGLYCERIDES STANDARD (1x 3mL) Unlabeled Vial | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
26 | 00817274021736 | A1CS1-0.5 | HEMOGLOBIN A1C CALIBRATOR SET (4x 0.5mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
27 | 00816776020537 | 186010253IVD | 186010253IVD | MassTrak™ Immunosuppressant Internal Standard Set | MassTrak | WATERS TECHNOLOGIES CORPORATION |
28 | 00816776020513 | 186010251IVD | 186010251IVD | MassTrak™ Immunosuppressant Calibrator Set | MassTrak | WATERS TECHNOLOGIES CORPORATION |
29 | 00816776020421 | 186009311IVD | 186009311IVD | MassTrak™ Endocrine Steroid Calibrator Set | MassTrak | WATERS TECHNOLOGIES CORPORATION |
30 | 00816467020068 | FT4 Cal | 25000016 | Calibrator Kit – Free T4 | QUALIGEN INC. | |
31 | 00816426020566 | KAI-016C | KAI-016C | For the calibration of the K-ASSAY® Alpha-1 AG, Alpha-1 AT, Complement C3, Comle For the calibration of the K-ASSAY® Alpha-1 AG, Alpha-1 AT, Complement C3, Comlement C4, Haptoglobin, IgA, IgG, IgM, and Transferrin assays. | K-ASSAY® Multi-Analyte Calibrator | KAMIYA BIOMEDICAL COMPANY, LLC |
32 | 00816426020542 | KAI-008C | KAI-008C | For the calibration of the K-ASSAY® Apo AI and Apo B assays. | K-ASSAY® Apo AI/B Calibrator | KAMIYA BIOMEDICAL COMPANY, LLC |
33 | 00812137012111 | 10 x 5mL, 1 x 50mL | 502-151 | The Chemistry calibrator is for use as a calibrator of CDS clinical chemistry as The Chemistry calibrator is for use as a calibrator of CDS clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures. The Chemistry calibrator is a human based serum. The concentration of the calibrator components have been adjusted to ensure optimal calibration of the CDS methods on specified analyzers. The product consists of lyophilized human serum and a diluent for reconstitution. The human serum contains additives to provide the defined assay values. The concentrations of the calibrator components are lot-specific. | Chemistry Calibrator Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
34 | 00811727013972 | 13-C7506-DIL-55 | 13-C7506-DIL-55 | 1 x 55 ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
35 | 00811727012753 | HP782-400 | HP782-400 | Microprotein Reagent, for the quantitative determination of total protein in uri Microprotein Reagent, for the quantitative determination of total protein in urine. Size: 8 x 50mL, 1 x 15mL STD | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
36 | 00811727011916 | P7582-240 | P7582-240 | Pointe Scientific, Inc. Microprotein Reagent for the quantitative determination Pointe Scientific, Inc. Microprotein Reagent for the quantitative determination of total protein in urine. | Pointe Scientific, Inc. Microprotein | POINTE SCIENTIFIC, INC. |
37 | 00811727010704 | C7506-50 | C7506-50 | The Multi-Analyte Chemistry calibrator is for use as a calibrator of Pointe Scie The Multi-Analyte Chemistry calibrator is for use as a calibrator of Pointe Scientific Inc. clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures. | POINTE SCIENTIFIC Chemistry Calibrator | POINTE SCIENTIFIC, INC. |
38 | 00657498001875 | 20270473 | 20270473 | Ion-Selective Reference Electrode for the determination of sodium, potassium, an Ion-Selective Reference Electrode for the determination of sodium, potassium, and chloride in serum. | ISE Reference Electrode | STANBIO LABORATORY, L.P. |
39 | 00657498001806 | A469-97 | A469-97 | To provide calibration points for the Sodium, Potassium, and Chloride electrodes To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas® Chemistry Systems. | Standard 1 | STANBIO LABORATORY, L.P. |
40 | 00657498001790 | A469-98 | A469-98 | To provide calibration points for the Sodium, Potassium, and Chloride electrodes To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas Chemistry Systems. | Standard 2 | STANBIO LABORATORY, L.P. |
41 | 00657498001783 | A469-99 | A469-99 | To provide constant electrical potential through the reference electrode on the To provide constant electrical potential through the reference electrode on the ISE module of the Roche Cobas Chemistry Analyzer. | Reference Solution | STANBIO LABORATORY, L.P. |
42 | 00657498001769 | 20270478 | 20270478 | The ISE Calibrator 2 for the Sirrus® is an in vitro diagnostic calibrator system The ISE Calibrator 2 for the Sirrus® is an in vitro diagnostic calibrator system intended for use on the Sirrus® Chemistry Analyzer to calibrate the ISE module option for chloride, potassium and sodium. | Sirrus® ISE Calibrator 2 | STANBIO LABORATORY, L.P. |
43 | 00657498001752 | 20270477 | 20270477 | The ISE Calibrator 1 for the Sirrus® is an in vitro diagnostic calibrator system The ISE Calibrator 1 for the Sirrus® is an in vitro diagnostic calibrator system intended for use on the Sirrus® Chemistry Analyzer to calibrate the ISE module option for chloride, potassium and sodium. | Sirrus® ISE Calibrator 1 | STANBIO LABORATORY, L.P. |
44 | 00657498001127 | 0550-605 | 0550-605 | For use as a multi-calibrator serum to calibrate different chemistry reagent use For use as a multi-calibrator serum to calibrate different chemistry reagent used in manual and automated clinical chemistry methods. | Ser-T-Cal Multicalibrator | STANBIO LABORATORY, L.P. |
45 | 00630414981147 | 10697937 | 10697937 | The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urin The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu | CLINITEK Novus® Automated Urine Chemistry Analyzer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
46 | 00630414981130 | 10494134 | 10494134 | The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urin The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu | CLINITEK Novus® Automated Urine Chemistry Analyzer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
47 | 00630414976631 | 10463372 | RC640 | LOCI Anemia Calibrator, 2 X 5 X 1.0 mL | Dimension® ANEM CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
48 | 00630414948508 | 10716281 | KC110B | Chemistry 1 Calibrator, 6 (3A x 2.3 mL; 3B x 2.3 mL) | Dimension Vista® CHEM 1 CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
49 | 00630414948034 | 10711580 | DC130 | Chemistry III Calibrator, 3x2x2.5mL | Dimension® CHEM III CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
50 | 00630414948027 | 10711579 | KC130A | Chemistry 3 Calibrator, 6 (3A x 2.5 mL; 3B x 2.5 mL) | Dimension Vista® CHEM 3 CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |