No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 14560189212463 | N/A | LCP | Assay, Glycosylated Hemoglobin | ST AIA-PACK HbA1c | |||
2 | 14560189212135 | N/A | KHQ | Radioassay, Triiodothyronine Uptake | ST AIA-PACK T-U | |||
3 | 14560189212005 | N/A | CGN | Acid, Folic, Radioimmunoassay | AIA-PACK RBC FOLATE | |||
4 | 04560189211827 | N/A | CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | AIA-PACK PRL CALIBRATOR SET | ||
5 | 04560189211407 | N/A | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | AIA-PACK IRI CALIBRATOR SET | ||
6 | 04560189211292 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | AIA-PACK FSH Sample Diluting Solution | ||
7 | 04560189212299 | N/A | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AIA-PACK bHCG Calibration Verification Test Set | ||
8 | 04560189212022 | N/A | CGN | Acid, Folic, Radioimmunoassay | 2 | AIA-PACK RBC FOLATE HEMOLYZING REAGENT SET | ||
9 | 14560189212739 | N/A | CHP | Radioimmunoassay, Estradiol | ST AIA-PACK hsE2 | |||
10 | 14560189212517 | N/A | CKG | Radioimmunoassay, Acth | ST AIA-PACK ACTH | |||
11 | 14560189212104 | n/a | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | ST AIA-PACK PA | |||
12 | 14560189211916 | N/A | CGN | Acid, Folic, Radioimmunoassay | AIA-PACK Folate | |||
13 | 04560189211940 | N/A | CGN | Acid, Folic, Radioimmunoassay | 2 | AIA-PACK Floate Sample Diluting Solution | ||
14 | 14560189211879 | N/A | CDD | Radioassay, Vitamin B12 | AIA-PACK B12 | |||
15 | 04560189211889 | N/A | CDD | Radioassay, Vitamin B12 | 2 | AIA-PACK B12 Calibrator Set | ||
16 | 04560189211650 | N/A | CEP | Radioimmunoassay, Luteinizing Hormone | 1 | ST AIA-PACK LH II CALIBRATOR SET | ||
17 | 04560189211445 | N/A | CFL | Radioimmunoassay, Human Growth Hormone | 1 | AIA-PACK HGH Calibrator Set | ||
18 | 04560189211391 | N/A | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | AIA-PACK IRI SAMPLE DILUTING SOLUTION | ||
19 | 04560189211308 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | AIA-PACK FSH Calibrator Set | ||
20 | 14560189210834 | N/A | CFT | Radioimmunoassay, Prolactin (Lactogen) | ST AIA-PACK PRL | |||
21 | 14560189210483 | N/A | DBF | Ferritin, Antigen, Antiserum, Control | ST AIA-PACK FER | |||
22 | 14560189210391 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | ST AIA-PACK FSH | |||
23 | 14560189210360 | N/A | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | ST AIA-PACK TSH | ||
24 | 14560189210285 | N/A | CDP | Radioimmunoassay, Total Triiodothyronine | ST AIA-PACK FT3 | |||
25 | 14560189210117 | N/A | MMI | Immunoassay Method, Troponin Subunit | ST AIA-PACK cTnI 2 | |||
26 | 04560189212817 | N/A | LPS | Urinary Homocystine (Nonquantitative) Test System | 2 | ST AIA-PACK Homocysteine Pretreatment Set | ||
27 | 04560189212800 | N/A | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AIA-PACK Homocysteine Control Set | ||
28 | 04560189212596 | N/A | JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | ST AIA-PACK DHEA-S Sample Diluting Solution | ||
29 | 04560189211285 | N/A | CHP | Radioimmunoassay, Estradiol | 1 | ST AIA-PACK E2 CALIBRATOR SET | ||
30 | 04560189211278 | N/A | CHP | Radioimmunoassay, Estradiol | 1 | AIA-PACK E2 Sample Diluting Solution | ||
31 | 04560189211148 | N/A | LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 | AIA-PACK CA 125 Calibrator Set | ||
32 | 04560189211124 | N/A | NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pa System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | 2 | AIA-PACK CA 19-9 Sample Diluting Solution | ||
33 | 04560189211100 | N/A | MOI | System, Test, Immunological, Antigen, Tumor | 2 | AIA-PACK 27.29 Calibrator Set | ||
34 | 14560189212173 | N/A | NDY | Test, Cystatin C | ST AIA-PACK Cystatin C | |||
35 | 04560189211902 | N/A | CDD | Radioassay, Vitamin B12 | 2 | AIA-PACK B12 Sample Diluting Solution | ||
36 | 04560189211780 | N/A | DHX | System, Test, Carcinoembryonic Antigen | 2 | AIA-PACK CEA Sample Diluting Solution | ||
37 | 04560189211421 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK Intact PTH CALIBRATOR SET | ||
38 | 04560189211414 | N/A | CEW | Radioimmunoassay, Parathyroid Hormone | 2 | ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION | ||
39 | 04560189211353 | N/A | JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | AIA-PACK βHCG Calibrator Set | ||
40 | 14560189210780 | N/A | DHX | System, Test, Carcinoembryonic Antigen | ST AIA-PACK CEA | |||
41 | 14560189213125 | N/A | MRG | System, Test, Vitamin D | ST AIA-PACK 25-OH Vitamin D | |||
42 | 14560189210179 | N/A | MOI | System, Test, Immunological, Antigen, Tumor | ST AIA-PACK 27.29 | |||
43 | 14560189210155 | N/A | DGC | Ige, Antigen, Antiserum, Control | ST AIA-PACK IgEII | |||
44 | 04560189284005 | N/A | KHO | Fluorometer, For Clinical Use | 1 | 9tray Sorter | ||
45 | 04560189283992 | AIA-900 | KHO | Fluorometer, For Clinical Use | 1 | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900 | ||
46 | 04560189283619 | N/A | LCP | Assay, Glycosylated Hemoglobin | 2 | G8 Variant Elution Buffer HSi No.2 (S) | ||
47 | 04560189213395 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK PROG II CALIBRATOR SET | ||
48 | 04560189213371 | N/A | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION | ||
49 | 04560189213333 | N/A | JIT | Calibrator, Secondary | 2 | AIA-PACK C-Peptide II Calibrator Set | ||
50 | 04560189213135 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK 25-OH Vitamin D CALIBRATOR SET |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 05055273216882 | CYS10445 | CYS10445 | Intended for in vitro diagnostic (IVD) use in the calibration of Randox Cystatin Intended for in vitro diagnostic (IVD) use in the calibration of Randox Cystatin C assay. For use in a clinical laboratory setting by trained personnel. | CYSTATIN C CALIBRATOR (CYSC CAL) | RANDOX LABORATORIES LIMITED |
2 | 05055273215557 | TF10161 | TF10161 | The Randox Soluble Transferrin Receptors Calibrator Series is intended for use i The Randox Soluble Transferrin Receptors Calibrator Series is intended for use in the calibration of Soluble Transferrin Receptors assays. | SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES (STFR CAL) | RANDOX LABORATORIES LIMITED |
3 | 05055273215540 | HA8124 | HA8124 | The HbA1c II Calibrator is intended for use in the calibration of the HbA1c II assay. | HbA1c II CALIBRATOR SET (HbA1c II CAL) | RANDOX LABORATORIES LIMITED |
4 | 05055273214550 | SC10154 | SC10154 | This product is intended for in vitro diagnostic use, in the calibration of the This product is intended for in vitro diagnostic use, in the calibration of the Randox Ransel assay. | RANSEL CALIBRATOR (RANSEL CAL) | RANDOX LABORATORIES LIMITED |
5 | 05055273213904 | AO2800 | ADIPONECTIN CALIBRATOR (ADPN CAL) | RANDOX LABORATORIES LIMITED | ||
6 | 05055273209204 | LP5047 | APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) | RANDOX LABORATORIES LIMITED | ||
7 | 05055273208733 | FR4030 | FR4030 | FRUCTOSAMINE (FRUC) | RANDOX LABORATORIES LIMITED | |
8 | 05055273208436 | CH5050 | sLDL CALIBRATOR (sLDL CAL) | RANDOX LABORATORIES LIMITED | ||
9 | 05055273208405 | CG5037 | COAGULATION CALIBRATOR (COAG CAL) | RANDOX LABORATORIES LIMITED | ||
10 | 05055273207842 | DA2700 | DA2700 | The Randox Cannabinoid Calibrator Set is intended for use in the calibration of The Randox Cannabinoid Calibrator Set is intended for use in the calibration of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. | THC CAL | RANDOX LABORATORIES LIMITED |
11 | 05055273207439 | CYS2699 | CYS2699 | The device is intended to be used for in the calibration of Cystatin C assays. | CYSC CAL | RANDOX LABORATORIES LIMITED |
12 | 05055273204520 | MA1567 | MICROALBUMIN CALIBRATOR SERIES (mALB CAL) | RANDOX LABORATORIES LIMITED | ||
13 | 05055273204285 | LO2306 | ANTI-STREPTOLYSIN O STANDARD (ASO STD) | RANDOX LABORATORIES LIMITED | ||
14 | 05055273204056 | IT3861 | IMMUNOGLOBULIN LIQUID PROTEIN CALIBRATOR (IG CAL) | RANDOX LABORATORIES LIMITED | ||
15 | 05055273203424 | GR2609 | GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL) | RANDOX LABORATORIES LIMITED | ||
16 | 05055273203110 | FR2993 | FR2993 | This product is intended for in vitro diagnostic use in the calibration of the R This product is intended for in vitro diagnostic use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. | FRUC CAL | RANDOX LABORATORIES LIMITED |
17 | 05055273201451 | CK2393 | CK2393 | The device is intended for use in the calibration of CK-MB assays in clinical ch The device is intended for use in the calibration of CK-MB assays in clinical chemistry systems. | CK-MB CAL | RANDOX LABORATORIES LIMITED |
18 | 05055273200768 | BM1362 | BETA 2 MICROGLOBULIN CALIBRATOR (B2M CAL) | RANDOX LABORATORIES LIMITED | ||
19 | 05055273200089 | AD5000 | AD5000 | The Aldolase Calibration Serum is intended for in vitro diagnostic use, in the c The Aldolase Calibration Serum is intended for in vitro diagnostic use, in the calibration of the Aldolase assay AD189. | ALS CAL | RANDOX LABORATORIES LIMITED |
20 | 05051700016698 | NK012.10S | Human IgM kit for use on SPAPLUS- Bulk Kit | THE BINDING SITE GROUP LIMITED | ||
21 | 05051700012249 | NK012.S | Human IgM kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | ||
22 | 04987486015147 | 103400 | The Calibrator 80 is for the calibration of the ADAMS A1c HA-8180 system used fo The Calibrator 80 is for the calibration of the ADAMS A1c HA-8180 system used for the quantitative determination of Hemoglobin A1c (HbA1c) in human whole blood and hemolysate samples. Bi-level calibrators (low and high) lyophilized calibrator from human-sourced hemoglobin. | Calibrator 80 | ARKRAY USA, INC. | |
23 | 04987481164475 | 999-61201 | 999-61201 | In-Vitro Diagnostic Use | uTASWako DCP Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
24 | 04987481164437 | 997-60901 | 997-60901 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
25 | 04987270234181 | 234181 | Lumipulse G HE4 Calibrators | FUJIREBIO INC. | ||
26 | 04987270234150 | 234150 | Lumipulse G BRAHMS PCT Calibrator Set | FUJIREBIO INC. | ||
27 | 04987270234020 | 234020 | Lumipulse G 25-OH Vitamin D Calibrators | FUJIREBIO INC. | ||
28 | 04987270233849 | 233849 | Lumipulse G E2-III Calibrators | FUJIREBIO INC. | ||
29 | 04987270231135 | 231135 | Lumipulse G TSH-III Calibrators | FUJIREBIO INC. | ||
30 | 04987270230954 | 230954 | Lumipulse G Prolactin Calibrators | FUJIREBIO INC. | ||
31 | 04987270230930 | 230930 | Lumipulse G FSH-N Calibrators | FUJIREBIO INC. | ||
32 | 04987270230916 | 230916 | Lumipulse G LH Calibrators | FUJIREBIO INC. | ||
33 | 04987270230893 | 230893 | Lumipulse G Progesterone-N Calibrators | FUJIREBIO INC. | ||
34 | 04987270230688 | 230688 | Lumipulse G CA125II Calibrators | FUJIREBIO INC. | ||
35 | 04987153301054 | G252GA | G252GA | Calibrator L (1 mL × 1), Calibrator H (1 mL × 1) | Calibrator for Lucica® Glycated Albumin-L | ASAHI KASEI PHARMA CORPORATION |
36 | 04560189213456 | N/A | ST AIA-PACK PROG III CALIBRATOR SET | TOSOH CORPORATION | ||
37 | 04560189213395 | N/A | ST AIA-PACK PROG II CALIBRATOR SET | TOSOH CORPORATION | ||
38 | 04560189213364 | N/A | ST AIA-PACK SHBG CALIBRATOR SET | TOSOH CORPORATION | ||
39 | 04560189213333 | N/A | AIA-PACK C-Peptide II Calibrator Set | TOSOH CORPORATION | ||
40 | 04560189213135 | N/A | ST AIA-PACK 25-OH Vitamin D CALIBRATOR SET | TOSOH CORPORATION | ||
41 | 04560189212886 | N/A | 0025328 | ST AIA-PACK BNP CALIBRATOR SET | TOSOH CORPORATION | |
42 | 04560189212787 | N/A | ST AIA-PACK Homocysteine Calibrator Set | TOSOH CORPORATION | ||
43 | 04560189212749 | N/A | ST AIA-PACK hsE2 CALIBRATOR SET | TOSOH CORPORATION | ||
44 | 04560189212589 | N/A | ST AIA-PACK DHEA-S CALIBRATOR SET | TOSOH CORPORATION | ||
45 | 04560189212534 | N/A | ST AIA-PACK ACTH Calibrator Set | TOSOH CORPORATION | ||
46 | 04560189212190 | N/A | ST AIA-PACK Cystatin C Calibatator Set | TOSOH CORPORATION | ||
47 | 04560189211988 | n/a | AIA-PACK PA CALBRATOR SET | TOSOH CORPORATION | ||
48 | 04560189211421 | N/A | ST AIA-PACK Intact PTH CALIBRATOR SET | TOSOH CORPORATION | ||
49 | 04560189211032 | N/A | ST AIA-PACK cTnI 2 Calibatator Set | TOSOH CORPORATION | ||
50 | 04250317546333 | 4009 | 4009 | Urine Calibration Standard Serotonin | Urine Calibration Standard | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |