No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | M52592330 | 9233 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | Antiserum to Human Serum | ||
2 | M52590150 | 9015 | JZR | SUPPORT GELS | 1 | IEP Sponge Wicks (2/pkg) | ||
3 | M52558520 | 5852 | JOZ | SYSTEM, AUTOMATED PLATELET AGGREGATION | 2 | Plateletworks Combo-25 Kit | ||
4 | M5255526140 | 552614 | JHO | ELECTROPHORETIC SEPARATION, LIPOPROTEINS | 1 | SPIFE Vis Cholesterol Kit | ||
5 | M5255527030 | 552703 | CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 2 | SPIFE Nexus IFE-6 Antisera Kit | ||
6 | M525AQCHP0 | AQC-HP | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | Actalyke QC Kit - AQC-HP | ||
7 | M52552920 | 5292 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | Protein S ELISA Kit | ||
8 | M52551280 | 5128 | GKA | ABNORMAL HEMOGLOBIN QUANTITATION | 2 | Hemolysate Reagent | ||
9 | M52590140 | 9014 | JJN | APPARATUS, ELECTROPHORESIS, FOR CLINICAL USE | 1 | Zip Zone Sponge Wicks | ||
10 | M5258JF520010 | 8JF52001 | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | AggRAM Module (Domestic) | ||
11 | M52563000000 | 6300000 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | Pipette, Variable Volume, 10-100 microliter | ||
12 | M52557700040 | 5770004 | JBP | ACTIVATED WHOLE BLOOD CLOTTING TIME | 2 | Actalyke XL, (CSA/CE), W/ Flash Memory | ||
13 | M52556510 | 5651 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoCARE Office Pack | ||
14 | M52518200 | 1820 | CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 2 | V8 WASTE DRAWER PACK | ||
15 | M52592500 | 9250 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | Antiserum to Human IgE | ||
16 | M5255526040 | 552604 | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | SPIFE Alkaline Phosphatase Gel Kit | ||
17 | M5255525970 | 552597 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | Blade Applicator Kit, 12 Sample | ||
18 | M5255524710 | 552471 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | SPIFE SPE HI RES 20 KIT | ||
19 | M5255524570 | 552457 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE IgG IEF-10 Kit | ||
20 | M5255523040 | 552304 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | QUICKGEL SPE Gel Kit | ||
21 | M5255522890 | 552289 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE ULTRA IFE-6 ANTISERA KIT | ||
22 | M5255521640 | 552164 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE Ultra ImmunoFix-9 Antisera Kit | ||
23 | M5255521360 | 552136 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | QUICKGEL MODIFIED APPLICATOR BLADES AND DEEP WELL CUPS | ||
24 | M5255521250 | 552125 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE Ultra ImmunoFix-15 Antisera Kit | ||
25 | M5255519410 | 551941 | JHO | ELECTROPHORETIC SEPARATION, LIPOPROTEINS | 1 | SPIFE Vis Cholesterol Reagent Kit | ||
26 | M52553680 | 5368 | GHR | REAGENT, PLATELET AGGREGATION | 2 | Collagen Reagent | ||
27 | M52553600 | 5360 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | Rocket Stain | ||
28 | M52553410 | 5341 | JPD | HEMOGLOBIN A2 QUANTITATION | 2 | Beta-Thal HbA2 Quik Column Kit | ||
29 | M52553390 | 5339 | JCM | CONTROL, HEMOGLOBIN, ABNORMAL | 2 | Normal HbA2 Quik Column Control | ||
30 | M52551340 | 5134 | JJT | ENZYME CONTROLS (ASSAYED AND UNASSAYED) | 1 | CK/LD Isoenzyme Control (5 x 2 mL) | ||
31 | M52551270 | 5127 | GKA | ABNORMAL HEMOGLOBIN QUANTITATION | 2 | Hemolysate Reagent | ||
32 | M52551250 | 5125 | GKA | ABNORMAL HEMOGLOBIN QUANTITATION | 2 | Hemolysate Reagent | ||
33 | M52551020 | 5102 | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | Alkaline Phosphatase Indolyl Blue Reagent Kit | ||
34 | M52550930 | 5093 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | Bufferizer | ||
35 | M52550900 | 5090 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | Zip Zone Prep (1 x 60 mL) | ||
36 | M52550850 | 5085 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoScreen-ES Take Home Pack | ||
37 | M52550830 | 5083 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoScreen III 1000 Slide Pack | ||
38 | M52550820 | 5082 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoScreen III Lab Pack | ||
39 | M52550050 | 5005 | KEM | AGENT, CLEARING | 1 | Clear Aid | ||
40 | M5255000910 | 500091 | KHE | REAGENT, OCCULT BLOOD | ColoScreen Developer | |||
41 | M52540840 | 4084 | JQW | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE | 1 | Super Z Applicator (8-sample) | ||
42 | M52536150 | 3615 | GJG | Pipette, Quantitative, Hematology | 1 | H-Pette II (No Blade, Metal Canula) (1000 pieces) | ||
43 | M52536120 | 3612 | GJG | Pipette, Quantitative, Hematology | 1 | H-Pette with Blade (1000 pieces) | ||
44 | M52534270 | 3427 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | SPIFE Urine/CSF Protein Accessories (50 templates plus blotters) | ||
45 | M52534260 | 3426 | JBD | SYSTEM, ANALYSIS, ELECTROPHORETIC HEMOGLOBIN | 2 | QuickGel Accessory Kit | ||
46 | M52534250 | 3425 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | SPE Abnormal Control (10 x 2 mL) | ||
47 | M52530580 | 3058 | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | TITAN GEL Alkaline Phosphatase Kit | ||
48 | M52530410 | 3041 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | TITAN GEL Serum Protein Kit | ||
49 | M52530240 | 3024 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | Titan III Cellulose Acetate (94 x 76 mm) | ||
50 | M52523190 | 2319 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | SPIFE 4000 Applicator Blades |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10304040102524 | 5701171 | 5701171 | Positive/Negative Controls for OC-Light and OC-Light S | Henry Schein | HENRY SCHEIN, INC. |
2 | 10304040102517 | 5701172 | 5701172 | Sampling Bottles OC-Light S | Henry Schein | HENRY SCHEIN, INC. |
3 | 10304040054175 | 5700609 | 5700609 | Test Kit OC-Light S | Henry Schein | HENRY SCHEIN, INC. |
4 | 10304040054168 | 5700607 | 5700607 | OC Light S FIT Personal Use Kit | Henry Schein | HENRY SCHEIN, INC. |
5 | M52556560 | 5656 | ColoCARE Hospital Pack | HELENA LABORATORIES CORPORATION | ||
6 | M52556510 | 5651 | ColoCARE Office Pack | HELENA LABORATORIES CORPORATION | ||
7 | M52556500 | 5650 | ColoCARE Screening Pack | HELENA LABORATORIES CORPORATION | ||
8 | M5255521380 | 552138 | ColoCare - 9 Health Fair | HELENA LABORATORIES CORPORATION | ||
9 | M5255520520 | 552052 | ColoScreen Triples 1000 Pack w/o Developer | HELENA LABORATORIES CORPORATION | ||
10 | M5255515650 | 551565 | ColoScreen | HELENA LABORATORIES CORPORATION | ||
11 | M5255515470 | 551547 | ColoCare - NR | HELENA LABORATORIES CORPORATION | ||
12 | M52550880 | 5088 | ColoScreen-ES Developer-15 | HELENA LABORATORIES CORPORATION | ||
13 | M52550860 | 5086 | ColoScreen-ES Lab Pack | HELENA LABORATORIES CORPORATION | ||
14 | M52550850 | 5085 | ColoScreen-ES Take Home Pack | HELENA LABORATORIES CORPORATION | ||
15 | M52550830 | 5083 | ColoScreen III 1000 Slide Pack | HELENA LABORATORIES CORPORATION | ||
16 | M52550820 | 5082 | ColoScreen III Lab Pack | HELENA LABORATORIES CORPORATION | ||
17 | M52550790 | 5079 | ColoScreen Tape | HELENA LABORATORIES CORPORATION | ||
18 | M52550780 | 5078 | ColoScreen Developer 2 | HELENA LABORATORIES CORPORATION | ||
19 | M52550760 | 5076 | ColoScreen 1000 Slide Pack | HELENA LABORATORIES CORPORATION | ||
20 | M52550730 | 5073 | ColoScreen III Take Home Pack | HELENA LABORATORIES CORPORATION | ||
21 | M52550720 | 5072 | ColoScreen Lab Pack | HELENA LABORATORIES CORPORATION | ||
22 | M52550710 | 5071 | ColoScreen III Office Pack | HELENA LABORATORIES CORPORATION | ||
23 | M52550640 | 5064 | ColoScreen iFOBT Office Kit | HELENA LABORATORIES CORPORATION | ||
24 | M52550631 | 5063 | ColoScreen iFOBT Mailer | HELENA LABORATORIES CORPORATION | ||
25 | M52550621 | 5062 | ColoScreen iFOBT Cassettes | HELENA LABORATORIES CORPORATION | ||
26 | M52550611 | 5061 | ColoScreen iFOBT Collection Tubes | HELENA LABORATORIES CORPORATION | ||
27 | M5255000910 | 500091 | ColoScreen Developer | HELENA LABORATORIES CORPORATION | ||
28 | M52510020 | 1002 | ColoScreen III Mailing Envelopes | HELENA LABORATORIES CORPORATION | ||
29 | 08806125630229 | IM706-100M | The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an imm The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an immunochomatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices. | OcculTech Fecal Occult Blood Rapid Test | YD DIAGNOSTICS CORP. | |
30 | M220P088283 | P080028 | P080028 | Pro Advantage FOB Developer Solutions 8X10ML 8/BX | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
31 | M220P0800183 | P080018 | P080018 | Pro Advantage FOB Lab Pack 100/BX | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
32 | 08305900100013 | 1000-1 | Home Test For Hidden Blood in The Stool | EZ Detect Colon Disease Test | BIOMERICA, INC. | |
33 | 08305900010015 | 1001 | The EZ DETECT Test is for in vitro qualitative detection of occult blood in the The EZ DETECT Test is for in vitro qualitative detection of occult blood in the stool -- an early indicator of various gastrointestinal bleeding disorders. The test is dispensed by the physician to the patient for home use. | EZ Detect Fecal Occult Blood Test | BIOMERICA, INC. | |
34 | 06970277512473 | TFO-602 | TFO-602 | FOB Rapid Test Cassette Box of 25 kits. | FOB Rapid Test Cassette | HANGZHOU ALLTEST BIOTECH CO., LTD. |
35 | 04015630946426 | 7790228001 | 7790228001 | Urisys 1100 Urine Analyzer | ROCHE DIAGNOSTICS GMBH | |
36 | 00893230002032 | KT-313 | KT-313 | Fecal Occult Blood Test | EDI™ CARE™ | EPITOPE DIAGNOSTICS INC |
37 | 00860146001527 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
38 | 00860146001510 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
39 | 00860146001503 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
40 | 00857338006934 | T1-CK50MUS | T1-CK50MUS | Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit with Mailers Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit with Mailers (Made in USA) | HEMOSURE® | HEMOSURE INC. |
41 | 00857338006323 | T1-TB50 | T1-TB50 | Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels) | HEMOSURE® | HEMOSURE INC. |
42 | 00857338006316 | T1-CM50 | T1-CM50 | Hemosure iFOB 50 Mailers Only Box Set | HEMOSURE® | HEMOSURE INC. |
43 | 00857338006309 | T1-CK30 | T1-CK30 | Hemosure iFOB Test 30 Cassettes and 50 Collection Tubes per Box Kit with Mailers | HEMOSURE® | HEMOSURE INC. |
44 | 00857338006194 | T1-TB10 | T1-TB10 | Hemosure iFOB Buffer Tube Box Set (10 Purple Cap Tubes with Short Labels) | HEMOSURE® | HEMOSURE INC. |
45 | 00857338006132 | T1-CM50 | T1-CM50 | Hemosure FOB 50 Mailers Only Box Set | HEMOSURE | HEMOSURE INC. |
46 | 00857338006125 | DUO-CM10 | DUO-CM10 | Hemosure iFOB Prepacked 10 Mailers Box Set with Two Buffer Tubes in Each Mailer | HEMOSURE® | HEMOSURE INC. |
47 | 00857338006118 | T1-TB50 | T1-TB50 | Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels) | HEMOSURE | HEMOSURE INC. |
48 | 00857338006101 | Prepack-CM25 | Prepack-CM25 | Individual Prepacked Mailer with One Tube in Each Mailer; Packed in a Plastic Bag | HEMOSURE® | HEMOSURE INC. |
49 | 00857338006095 | DUO-iFOB20 | DUO-iFOB20 | Hemosure iFOB Prepacked DUO-iFOB Test 20 Cassettes and 10 Mailers Box Kit with T Hemosure iFOB Prepacked DUO-iFOB Test 20 Cassettes and 10 Mailers Box Kit with Two Buffer Tubes in Each Mailer | HEMOSURE® | HEMOSURE INC. |
50 | 00857338006088 | T1-CK30T | T1-CK30T | Hemosure iFOB Test 30 Cassettes and 30 Collection Tubes per Box Kit without Mailer | HEMOSURE® | HEMOSURE INC. |