| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00816879026337 | F282 | 746870 | MVU | Reagents, Specific, Analyte | 1 | Nutmeg, Myristica fragrans | |
| 2 | 00816879026313 | F280 | 74290 | MVU | Reagents, Specific, Analyte | 1 | Black Pepper, Piper nigrum | |
| 3 | 00816879026214 | F214 | 74581 | MVU | Reagents, Specific, Analyte | 1 | Spinach, Spinacia oleracea | |
| 4 | 00816879026146 | F95 | 74657 | MVU | Reagents, Specific, Analyte | 1 | Peach, Prunus persica | |
| 5 | 00816879026092 | F53 | 742680 | MVU | Reagents, Specific, Analyte | 1 | Scallop | |
| 6 | 00816879026078 | F242 | 743210 | MVU | Reagents, Specific, Analyte | 1 | Bing Cherry, Prunus avium | |
| 7 | 00816879026061 | W45 | 745050 | MVU | Reagents, Specific, Analyte | 1 | Alfalfa, Medicago sativa | |
| 8 | 00816879026047 | F139 | 745790 | MVU | Reagents, Specific, Analyte | 1 | Goat's Cheese | |
| 9 | 00816879025941 | F119 | 746170 | MVU | Reagents, Specific, Analyte | 1 | Radish, Raphanus sativus | |
| 10 | 00816879025743 | F236 | 741640 | MVU | Reagents, Specific, Analyte | 1 | Whey | |
| 11 | 00816879025699 | F212 | 742990 | MVU | Reagents, Specific, Analyte | 1 | Mushroom, Agaricus hortensis/bisporus | |
| 12 | 00816879025668 | F183 | 745690 | MVU | Reagents, Specific, Analyte | 1 | Sunflower Seed | |
| 13 | 00816879025606 | W18 | 74479 | MVU | Reagents, Specific, Analyte | 1 | Sheep Sorrel, Red Rumex acetosella | |
| 14 | 00816879025583 | F290 | 742550 | MVU | Reagents, Specific, Analyte | 1 | Oyster, Ostrea sp. | |
| 15 | 00816879025538 | F218 | 746880 | MVU | Reagents, Specific, Analyte | 1 | Paprika, Capsicum annuum | |
| 16 | 00816879023596 | G006 | 63283 | DHB,JJE | System, Test, Radioallergosorbent (Rast) Immunological,Analyzer, Chemistry (Phot System, Test, Radioallergosorbent (Rast) Immunological,Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | NOVEOS Timothy Grass, Phleum pratense | |
| 17 | 00816879023510 | D002 | 63208 | DHB,JJE | System, Test, Radioallergosorbent (Rast) Immunological,Analyzer, Chemistry (Phot System, Test, Radioallergosorbent (Rast) Immunological,Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | NOVEOS House Dust Mite, Dermatophagoides farinae | |
| 18 | 00816879023312 | I5 | 748440 | MVU | Reagents, Specific, Analyte | 1 | Yellow Hornet, Dolichovespula arenaria | |
| 19 | 00816879023008 | 63140 | DHB,JJE | System, Test, Radioallergosorbent (Rast) Immunological,Analyzer, Chemistry (Phot System, Test, Radioallergosorbent (Rast) Immunological,Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | NOVEOS IgE Common Kit | ||
| 20 | 00816879020243 | FGA24 | 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgA antibodies in human serum | MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 | Autostat II Anti-B2-Glycoprotein I IgA | |
| 21 | 00816879026351 | F234 | 746780 | MVU | Reagents, Specific, Analyte | 1 | Vanilla, Vanilla planifolia | |
| 22 | 00816879022315 | 288197 | 288197 | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Hytec Probe Cleaning Solution | |
| 23 | 00816879022223 | 309046 | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Total IgE Sample Diluent | ||
| 24 | 00816879022094 | 74129 | 74129 | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | IgE Extended Calibrator Set | |
| 25 | 00816879022025 | G016 | 743420 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Foxtail, Meadow Alopecurus pratensis |
| 26 | 00816879021882 | M009 | 74746 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Fusarium moniliforme |
| 27 | 00816879021776 | W016 | 74436 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | DGC | Ige, Antigen, Antiserum, Control | 2 | Marsh Elder, Rough Iva ciliata |
| 28 | 00816879021745 | W009 | 74432 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Plantain, English Plantago lanceolata |
| 29 | 00816879021462 | G003 | 74333 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | DGC | Ige, Antigen, Antiserum, Control | 2 | Orchard Grass Dactylis glomerata |
| 30 | 00816879021400 | G002 | 74326 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Bermuda Grass Cynodon dactylon |
| 31 | 00816879021202 | F007 | 74238 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Oat |
| 32 | 00816879021127 | D002 | 74202 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | House dust Mite D. farinae |
| 33 | 00816879020656 | F182 | 749060 | MVU | Reagents, Specific, Analyte | 1 | Lima Bean, Phaseolus limensis | |
| 34 | 00816879020557 | F219 | 748760 | MVU | Reagents, Specific, Analyte | 1 | Sage, Salvia officinalis | |
| 35 | 00081687902221 | 308174 | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | IgE Conjugate MCS | ||
| 36 | 00816879026276 | F90 | 74303 | MVU | Reagents, Specific, Analyte | 1 | Malt | |
| 37 | 00816879025460 | K80 | 747220 | MVU | Reagents, Specific, Analyte | 1 | Formaldehyde | |
| 38 | 00816879022988 | T12 | 749490 | MVU | Reagents, Specific, Analyte | 1 | Willow, Salix caprea | |
| 39 | 00816879026320 | F221 | 74280 | MVU | Reagents, Specific, Analyte | 1 | Coffee, Coffea spp. | |
| 40 | 00816879026269 | F315 | 74305 | MVU | Reagents, Specific, Analyte | 1 | Green Bean, Phaseolus vulgaris | |
| 41 | 00816879026245 | F260 | 74570 | MVU | Reagents, Specific, Analyte | 1 | Broccoli, Brassica oleracea var. botrytis | |
| 42 | 00816879025989 | F273 | 745980 | MVU | Reagents, Specific, Analyte | 1 | Thyme, Thymus vulgaris | |
| 43 | 00816879025965 | F179 | 746090 | MVU | Reagents, Specific, Analyte | 1 | Raisin, Vitis sp | |
| 44 | 00816879025927 | F118 | 746250 | MVU | Reagents, Specific, Analyte | 1 | Zucchini, Cucurbita pepo | |
| 45 | 00816879025880 | M202 | 74163 | MVU | Reagents, Specific, Analyte | 1 | Acremonium kiliense, syn. Acremonium strictum | |
| 46 | 00816879025798 | F284 | 74580 | MVU | Reagents, Specific, Analyte | 1 | Turkey, Meleagris gallopavo | |
| 47 | 00816879025774 | F208 | 74626 | MVU | Reagents, Specific, Analyte | 1 | Lemon, Citrus limon | |
| 48 | 00816879025712 | F225 | 742880 | MVU | Reagents, Specific, Analyte | 1 | Pumpkin/ Summer Squash, Cucurbita pepo | |
| 49 | 00816879025682 | F261 | 743110 | MVU | Reagents, Specific, Analyte | 1 | Asparagus, Asparagus officinalis | |
| 50 | 00816879023947 | G004 | 8632810 | PUW | System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | 2 | NOVEOS Capture Reagent Pack Meadow Fescue, Festuca elatior |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00840239027757 | EIA-2775 | EIA-2775 | The DRG Rheumatoid Factor (RF) IgM ELISA test system is intended for the qualita The DRG Rheumatoid Factor (RF) IgM ELISA test system is intended for the qualitative and semi-quantitative detection of RF IgM-class antibody in human sera. The test system is intended to be used as an aid in the diagnosis of rheumatoid arthritis. | RF IgM (Rheumatoid Factor) ELISA | DRG INTERNATIONAL INC |
| 2 | 00817302021004 | CC629 | CC629 | RF (Rheumatoid Factor) 2 x 160 tests | CAROLINA LIQUID CHEMISTRIES CORP.® RF REAGENT CC629 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 3 | 00817302020991 | AU-629 | AU-629 | RF (Rheumatoid Factor) 3 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® RF RGT. KIT AU-629 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 4 | 00817302020984 | BL629 | BL629 | RF (Rheumatoid Factor) 2 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® RF RGT. KIT BL-629 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 5 | 00817273020389 | 720-710 | "720-710 Rheumatoid Factor Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
| 6 | 00816879020076 | FGA07 | 96 well ELISA for the detection of IgG Rheumatoid factor in human serum. | Autostat II IgG Rheumatoid Factor | HYCOR BIOMEDICAL LLC | |
| 7 | 00816879020069 | FGA06 | FGA06 | 96 well ELISA for the detection of IgA Rheumatoid Factor antibodies in human serum. | Autostat II IgA Rheumatoid Factor | HYCOR BIOMEDICAL LLC |
| 8 | 00816879020052 | FGA05 | 96 well ELISA for the detection of IgM Rheumatoid Factor antibodies in human serum. | Autostat II IgM Rheumatoid Factor | HYCOR BIOMEDICAL LLC | |
| 9 | 00816426021457 | KAI-230 | KAI-230 | For the quantitative determination of human rheumatoid factor (RF) in serum and For the quantitative determination of human rheumatoid factor (RF) in serum and plasma by immunoturbidimetric assay. | K-ASSAY® RF Reagent (Ver.2) | KAMIYA BIOMEDICAL COMPANY, LLC |
| 10 | 00816426020429 | KAI-032C | KAI-032C | For the calibration of the K-ASSAY® RF assay. | K-ASSAY® RF Calibrator | KAMIYA BIOMEDICAL COMPANY, LLC |
| 11 | 00816426020191 | KAI-031 | KAI-031 | For the quantitative determination of human rheumatoid factor (RF) in serum by i For the quantitative determination of human rheumatoid factor (RF) in serum by immunoturbidimetric assay. | K-ASSAY® RF Reagent | KAMIYA BIOMEDICAL COMPANY, LLC |
| 12 | 00816057021642 | NC-705001 | NC705001 | Detection of Rheumatoid Factor | ASI RF Direct Slide Test Control Set | ARLINGTON SCIENTIFIC, INC. |
| 13 | 00816057020508 | NC-7001000DC | NC-70010000DC | Detection of Rheumatoid Factor | ASI RF Direct Slide Test | ARLINGTON SCIENTIFIC, INC. |
| 14 | 00816057020492 | NC-700100DC-E | NC-700100DC-E | Detection fo Rheumatoid Factor, Export | ASI RF Direct Slide Test | ARLINGTON SCIENTIFIC, INC. |
| 15 | 00816057020485 | NC-700100DC | NC-700100DC | Detection of Rheumatoid Factor | ASI RF Direct Slide Test | ARLINGTON SCIENTIFIC, INC. |
| 16 | 00816057020478 | NC-700025DC-E | NC-700025DC-E | Detection of Rheumatoid Factor | ASI RF Direct Slide Tests for Export | ARLINGTON SCIENTIFIC, INC. |
| 17 | 00816057020461 | NC-700025DC | NC-700025DC | Detection of Rheumatoid Factor | ASI RF Direct Slide Test | ARLINGTON SCIENTIFIC, INC. |
| 18 | 00695684351007 | 35100 | Latex test for Rheumatoid Factor | AIM RF TEST | GERMAINE LABORATORIES, INC | |
| 19 | 00657498001271 | 1155-100 | 1155-100 | Latex agglutination slide test for the Qualitative and Semi-quantitative determi Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Rheumatoid Factor in non-diluted serum. | RaPET® RF | STANBIO LABORATORY, L.P. |
| 20 | 00657498001264 | 1155-050 | 1155-050 | Latex agglutination slide test for the Qualitative and Semi-quantitative determi Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Rheumatoid Factor in non-diluted serum. | RaPET® RF | STANBIO LABORATORY, L.P. |
| 21 | 00630414595603 | 11097618 | 11097618 | Rheumatoid Factors (RF) - Atellica CH - RGT - 360T | Atellica CH RF | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 22 | 00630414482385 | 10311894 | B01-4806-01 | RF - ADVIA Chem. - RGT - 2x100 tests | ADVIA® Chemistry RF Rheumatoid Factor Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 23 | 00628055726036 | 10503 | Pulse Scientific Inc. | PULSE SCIENTIFIC INC | ||
| 24 | 00613647001295 | T3018-7533 | 23046386 | SURE-VUE RF 500 TESTS | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 25 | 00613647001264 | T3018-7034 | 23038003 | SURE-VUE RF 50TEST/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 26 | 00613647001257 | T3018-7033 | 23038002 | SURE-VUE RF 100TEST/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 27 | 00382902780519 | 278051 | 278051 | BD Macro-Vue™ Card Test Rotator, Model 51 | BD Macro-Vue™ Card Test Rotator, Model 51 | BECTON, DICKINSON AND COMPANY |
| 28 | 00380740169992 | 04R9924 | 04R9924 | Rheumatoid Factor 400 Tests | Alinity | ABBOTT IRELAND |
| 29 | 00380740151058 | 04R9921 | 04R9921 | Alinity c Rheumatoid Factor Reagent Kit 400 Tests | Alinity | ABBOTT GMBH |
| 30 | 00380740028473 | 8G67-02 | 08G6702 | Rheumatoid Factor Calibrator | ARCHITECT | ABBOTT LABORATORIES |
| 31 | 00380740016531 | 8G66-21 | 08G6621 | Rheumatoid Factor | ARCHITECT | ABBOTT LABORATORIES |
| 32 | 00006136471295 | T3018-7533 | 23046386 | SURE-VUE RF 500 TESTS | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 33 | 00006136471264 | T3018-7034 | 23038003 | SURE-VUE RF 50TEST/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 34 | 00006136471257 | T3018-7033 | 23038002 | SURE-VUE RF 100TEST/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 35 | B224R201 | R-20 | R-20 | Cenogenics Corporation's RF LATEX TEST KIT is a rapid latex slide test for the d Cenogenics Corporation's RF LATEX TEST KIT is a rapid latex slide test for the determination of Rheumatoid Factor in human serum.Kit Contains:5 ml RF Latex Reagent10 ml Glycine-Saline Buffer Concentrate1 ml RF Positive Control1 ml RF Negative Control6-ring slideProduct Instructions | RF LATEX Test Kit | CENOGENICS CORPORATION |
| 36 | 20885380020220 | B1077-20 | B1077-20 | Rheumatoid Factor Test Slide CLIA Non-Waived | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 37 | 20885380020213 | B1077-19 | B1077-19 | SP RF Direct Slide Test 100 Determination | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 38 | 15099590226947 | 447070 | 447070 | IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent | IMMAGE | BECKMAN COULTER, INC. |
| 39 | 15099590010966 | OSR61105 | RF Latex | AU | BECKMAN COULTER, INC. | |
| 40 | 10859035006207 | 36045 | Wampole Colorcard® RF | ALERE NORTH AMERICA, LLC | ||
| 41 | 10859035006009 | 34S2 | RHEUMATEX® | ALERE NORTH AMERICA, LLC | ||
| 42 | 10758750006809 | 6801729 | 6801729 | VITROS Chemistry Products RF Reagent | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 43 | 10722355001538 | RHLX-100 | A rapid color enhanced undiluted latex slide test for the qualitative or semi- q A rapid color enhanced undiluted latex slide test for the qualitative or semi- quantitative determination of rheumatoid factor in serum | Detector Rheumacol Lex | IMMUNOSTICS COMPANY, INC | |
| 44 | 10722355001521 | RHLX-50 | A rapid color enhanced undiluted latex slide test for the qualitative or semi- q A rapid color enhanced undiluted latex slide test for the qualitative or semi- quantitative determination of rheumatoid factor in serum | Detector Rheumacol Lex | IMMUNOSTICS COMPANY, INC | |
| 45 | 10722355001514 | RH-100 | A rapid color enhanced hemagglutination slide test for the detection of rheumato A rapid color enhanced hemagglutination slide test for the detection of rheumatoid factor in serum or synovial fluid | Detector Rheumacol | IMMUNOSTICS COMPANY, INC | |
| 46 | 10722355001507 | RH-50 | A rapid color enhanced hemagglutination slide test for the detection of rheumato A rapid color enhanced hemagglutination slide test for the detection of rheumatoid factor in serum or synovial fluid | Detector Rheumacol | IMMUNOSTICS COMPANY, INC | |
| 47 | 10722355001477 | RA-100U | A rapid undiluted latex slide test for the detection of rheumatoid factors | Detector Lex RA | IMMUNOSTICS COMPANY, INC | |
| 48 | 10722355001460 | RA-50U | A rapid undiluted latex slide test for the detection of rheumatoid factors | Detector Lex RA | IMMUNOSTICS COMPANY, INC | |
| 49 | 08426950845249 | 701340 | 1. QUANTA Flash RF IgM Reagent Cartridge contains the following reagents for 100 1. QUANTA Flash RF IgM Reagent Cartridge contains the following reagents for 100 determinations:a. Rabbit pAb coated paramagnetic beads.b. Assay buffer - colored pink, containing proteing stabilizers and preservatives.c. Tracer IgM - Isoluminol labeled anti-human IgM antibody, containing buffer, protein stabilizers and preservatives. | QUANTA Flash RF IgM Reagents | INOVA DIAGNOSTICS, INC. | |
| 50 | 08426950835189 | 701345 | 1. QUANTA Flash RF IgA Reagent Cartridge contains the following reagents for 100 1. QUANTA Flash RF IgA Reagent Cartridge contains the following reagents for 100 determinations:a. Rabbit pAb coated paramagnetic beads.b. Assay buffer - colored pink, containing proteing stabilizers and preservatives.c. Tracer IgM - Isoluminol labeled anti-human IgA antibody, containing buffer, protein stabilizers and preservatives. | QUANTA Flash RF IgA Reagents | INOVA DIAGNOSTICS, INC. |