| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00810111410014 | BO20S | BO20S | A collection of in vitro diagnostic devices and materials available for use by a A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device. | PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | 2 | LetsGetChecked Blood Sample Collection Kit (FMHM) |
| 2 | 00850024881594 | BO06S | BO06S | A collection of in vitro diagnostic devices and materials available for use by a A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device. | PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | 2 | LetsGetChecked Blood Sample Collection Kit (TRFNUS+) |
| 3 | 00850024881310 | BO112, BO903, BO12S | BO112, BO903, BO12S | A collection of in vitro diagnostic devices and materials available for use by a A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device. | PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | 2 | LetsGetChecked Blood Sample Collection Kit (MHTB) |
| 4 | 00810111410311 | BU04S | BU04S | A collection of devices intended to be used by a layperson in the home for the c A collection of devices intended to be used by a layperson in the home for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula, cup], and a covered specimen receptacle(s) with or without an additive/medium (e.g., preservation solution, microbiological medium) and mailing packing/envelope. It may include other relevant devices (e.g., a lancet). This is a single-use device. | LetsGetChecked Blood and Urine Sample Collection Kit (ST05) | |||
| 5 | 00810111410175 | BO12S | BO12S | A collection of in vitro diagnostic devices and materials available for use by a A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device. | PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | 2 | LetsGetChecked Blood Sample Collection Kit (MHTB) |
| 6 | 00810111410106 | BO17S | BO17S | A collection of in vitro diagnostic devices and materials available for use by a A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device. | LetsGetChecked Blood Sample Collection Kit (HPSP) | |||
| 7 | 00850024881020 | BO125 | BO125 | A collection of in vitro diagnostic devices and materials available for use by a A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device. | PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | 2 | LetsGetChecked Blood Sample Collection Kit (FOLT) |
| 8 | 00810111410090 | BO18S | BO18S | A collection of in vitro diagnostic devices and materials available for use by a A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device | PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | 2 | LetsGetChecked Blood Sample Collection Kit (HPTT) |
| 9 | 00850024881471 | BO120, BO190 | BO120, BO190 | A collection of in vitro diagnostic devices and materials available for use by a A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device. | PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | 2 | LetsGetChecked Blood Sample Collection Kit (TRFN) |
| 10 | 00850024881327 | UO305, UO01S | UO305, UO01S | A collection of noninvasive devices intended to be used for the collection, and A collection of noninvasive devices intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation. | OIE | Urine Collection Kit (Excludes Hiv Testing) | 1 | LetsGetChecked Urine Sample Collection Kit (SM02) |
| 11 | 00810111410342 | BO07S | BO07S | A collection of in vitro diagnostic devices and materials available for use by a A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device | PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | 2 | LetsGetChecked Blood Sample Collection Kit (TRFN) |
| 12 | 00850024881242 | UO301, UO02S | UO301, UO02S | A collection of noninvasive devices intended to be used for the collection, and A collection of noninvasive devices intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation. | LetsGetChecked Urine Sample Collection Kit (BS03) |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00860006434540 | K1001-02 | The Tasso-M20 is used to collect, store, and transport capillary blood for testi The Tasso-M20 is used to collect, store, and transport capillary blood for testing in a centralized laboratory. It is to be used in non-clinical settings for use in adult populations. | Tasso-M20 | TASSO, INC | |
| 2 | 00855617006989 | 87135 | 87135 | Petters, 500 Petters | KOVA | KOVA INTERNATIONAL, INC. |
| 3 | 00855617006965 | 87137 | 87137 | Super Tubes, 500 Tubes | KOVA | KOVA INTERNATIONAL, INC. |
| 4 | 00855617006958 | 87138 | 87138 | Economy Tubes, 500 Tubes | KOVA | KOVA INTERNATIONAL, INC. |
| 5 | 00855617006941 | 87139 | 87139 | Caps, 500 Caps | KOVA | KOVA INTERNATIONAL, INC. |
| 6 | 00855617006934 | 87141 | 87141 | KO-LEC-PAC, 500 Determinations | KOVA | KOVA INTERNATIONAL, INC. |
| 7 | 00855617006910 | 87153 | 87153 | Super Pac 1000 and Caps | KOVA | KOVA INTERNATIONAL, INC. |
| 8 | 00855617006903 | 87155 | 87155 | Pac II | KOVA | KOVA INTERNATIONAL, INC. |
| 9 | 00855617006897 | 87156 | 87156 | Value Pac 500, 500 Determinations | KOVA | KOVA INTERNATIONAL, INC. |
| 10 | 00855617006873 | 87162 | 87162 | Super Pac 1000 | KOVA | KOVA INTERNATIONAL, INC. |
| 11 | 00855617006804 | 87140 | 87140 | 1000 Clear Automation Tubes with Conical Bottom | KOVA | KOVA INTERNATIONAL, INC. |
| 12 | 00855617006194 | 87139E | 87139E | Caps, 500 Caps | KOVA | KOVA INTERNATIONAL, INC. |
| 13 | 00855617006187 | 87135E | 87135E | Petters, 500 Petters | KOVA | KOVA INTERNATIONAL, INC. |
| 14 | 00855617006170 | 87138E | 87138E | Economy Tubes, 500 Tubes | KOVA | KOVA INTERNATIONAL, INC. |
| 15 | 00855617006163 | 87137E | 87137E | Super Tubes, 500 Tubes | KOVA | KOVA INTERNATIONAL, INC. |
| 16 | 00855617006101 | 87141E | 87141E | KO-LEC-PAC, 500 Determinations | KOVA | KOVA INTERNATIONAL, INC. |
| 17 | 00855617006095 | 87156E | 87156E | Value Pac 500, 500 Determinations | KOVA | KOVA INTERNATIONAL, INC. |
| 18 | 00855617006088 | 87155E | 87155E | Pac II | KOVA | KOVA INTERNATIONAL, INC. |
| 19 | 00855617006071 | 87162E | 87162E | Super Pac 1000 | KOVA | KOVA INTERNATIONAL, INC. |
| 20 | 00855617006064 | 87153E | 87153E | Super Pac 1000 and Caps | KOVA | KOVA INTERNATIONAL, INC. |
| 21 | 00850040712094 | ISR2-T-1200 | ISR2-T-1200 | iSWAB RNA v2 Collection Tube 1.0 ml | Mawi DNA Technologies | MAWI DNA TECHNOLOGIES, LLC |
| 22 | 00850040712087 | ISWAB-RNA-v2 | ISWAB-RNA-v2 | iSWAB RNA v2 Collection Kit 1.0 ml | Mawi DNA Technologies | MAWI DNA TECHNOLOGIES, LLC |
| 23 | 00850033297188 | 88100 | 88100 | Kova POC Urinalysis System Pac (Urinalysis package containing 100 plastic tubes, Kova POC Urinalysis System Pac (Urinalysis package containing 100 plastic tubes, 100 plastic tube caps, 100 plastic pipettes, and 10 10-chambered plastic microscope slides with gridlines) | Kova Plastics | ALLTRISTA PLASTICS LLC |
| 24 | 00850033297171 | KOVATUBESW | KOVATUBESW | Box containing 500 Kova Straight Wall Tubes (Plastic graduated sample tubes for Box containing 500 Kova Straight Wall Tubes (Plastic graduated sample tubes for urinalysis) | Kova Plastics | ALLTRISTA PLASTICS LLC |
| 25 | 00850033297119 | 87141 | 87141 / 87141E | Kova Ko-Lec-Pac (Urinalysis package containing 500 plastic tubes, 500 plastic ca Kova Ko-Lec-Pac (Urinalysis package containing 500 plastic tubes, 500 plastic caps, 500 plastic cups, and 500 labels) | Kova Plastics | ALLTRISTA PLASTICS LLC |
| 26 | 00850033297034 | KOVATUBE | 87138 / 87138E | Box of 500 Kova Econotubes (plastic graduated sample tubes) for use in urinalysis. | Kova Plastics | ALLTRISTA PLASTICS LLC |
| 27 | 00850033297027 | KOVASUPERTUBE | 87137 / 87137E | Box of 500 Kova Supertubes (plastic graduated sample tubes) for use in urinalysis. | Kova Plastics | ALLTRISTA PLASTICS LLC |
| 28 | 00850032976114 | 1 | Truepill Inc. | POSTMEDS, INC. | ||
| 29 | 00850024881259 | FT01S, FT102, FT101 | FT01S, FT102, FT101 | A collection of devices and materials intended to be used by a layperson in the A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. | LetsGetChecked Stool Sample Collection Kit | PRIVAPATH DIAGNOSTICS LIMITED |
| 30 | 00850015517105 | 4249 | 4249 | ONO PETTER, 1000/box | KOVA | KOVA INTERNATIONAL, INC. |
| 31 | 00850015517075 | 88100 | 88100 | KOVA-poc, Urinalysis System Pac | KOVA | KOVA INTERNATIONAL, INC. |
| 32 | 00850015517013 | 87154E | 87154E | Super-Pac 1000International | KOVA | KOVA INTERNATIONAL, INC. |
| 33 | 00850015517006 | 87154 | 87154 | Super-Pac 1000 | KOVA | KOVA INTERNATIONAL, INC. |
| 34 | 00840216120594 | LC6X9MEDX | 6" X 9", 1.5MIL CLEAR BAG, 5C, 2MIL FRONT POUCH, ADHESIVE CLOSURE W/ABSORBENT PA 6" X 9", 1.5MIL CLEAR BAG, 5C, 2MIL FRONT POUCH, ADHESIVE CLOSURE W/ABSORBENT PAD, 100/PK, 10/PKS, 1000/CS | MEDTOX LABORATORIES | ASP GLOBAL, LLC | |
| 35 | 00840216120570 | LC3X5BIO | 3"X5", 2.0MIL CLEAR BAG, 2C, SINGLE POCKET, ZIP LOCK CLOSURE, 100/PK, 10/PKS, 1,000 CS | LAPCORP | ASP GLOBAL, LLC | |
| 36 | 00840216120563 | LC12X15ORNG | 12" X 15", 2MIL ORANGE, 1.5MIL ORANGE BACK POUCH, NO PRINTING, ZIP LOCK, 100/PK 12" X 15", 2MIL ORANGE, 1.5MIL ORANGE BACK POUCH, NO PRINTING, ZIP LOCK, 100/PK, 10PKS/CS, 1,000/CASE | LAPCORP | ASP GLOBAL, LLC | |
| 37 | 00840216120488 | C-SESP06-01 | 7.25 X 29", 4MIL, SEACOLE E-Z SPREAD ICE MELT, LDPE CLEAR BAG W/CUSTOM ANGLE SEA 7.25 X 29", 4MIL, SEACOLE E-Z SPREAD ICE MELT, LDPE CLEAR BAG W/CUSTOM ANGLE SEAL, 100/PK, 10/PKS, 1000/CS | INTERNATIONAL PLASTICS INC. | ASP GLOBAL, LLC | |
| 38 | 00840216120433 | 22090 | 6X10 GEN PATH ONCOLOGY SPECIMEN TRANSPORT BAG | BIO REFERENCE LABORATORY | ASP GLOBAL, LLC | |
| 39 | 00840216120143 | BAG-DAY 3/RANDOM/ABS | SPECIMEN TRANSPORT BAG | GBF,INC. | ASP GLOBAL, LLC | |
| 40 | 00840216120075 | 161123-C | EMPLOYER SOLUTIONS-ADHESIVE BAG | QUEST | ASP GLOBAL, LLC | |
| 41 | 00840216120020 | 161123-10 | EMPLOYER SOLUTIONS-ADHESIVE BAG | QUEST | ASP GLOBAL, LLC | |
| 42 | 00840216120013 | 161123-25 | EMPLOYER SOLUTIONS-ADHESIVE BAG | QUEST | ASP GLOBAL, LLC | |
| 43 | 00840216119901 | 8.5X11EXAMONE | QUEST-EXAMONE BAG | QUEST | ASP GLOBAL, LLC | |
| 44 | 00840216119895 | LC6X10LBNP-D | SPECIMEN ONLY BAG W/BIOHAZARD IN SCORE LINE | LABCORP | ASP GLOBAL, LLC | |
| 45 | 00840216119888 | 504675BC | 6.75 X 11 LOCAL SPECIMEN BAG | QUEST | ASP GLOBAL, LLC | |
| 46 | 00840216119451 | POL-RWHM | ROUTINE SPECIMEN BAG,ZIP LOCK, REGIONAL WOMEN'S HEALTH MANAGEMENT, POL, BAR COD ROUTINE SPECIMEN BAG,ZIP LOCK, REGIONAL WOMEN'S HEALTH MANAGEMENT, POL, BAR CODED, 2000/CS | QUEST | ASP GLOBAL, LLC | |
| 47 | 00840216119420 | SNA1517 | 15" X 17" 2MIL BAG CLEAR, 2MIL UPPER FLAP, 1.5MIL BACK POUCH, ADHESIVE CLOSURE, 15" X 17" 2MIL BAG CLEAR, 2MIL UPPER FLAP, 1.5MIL BACK POUCH, ADHESIVE CLOSURE, 50/PK, 10/PKS, 500/CASE | ASP MEDICAL | ASP GLOBAL, LLC | |
| 48 | 00840216119352 | 504122BC | QUANTIFERON REFRIGRATE BAG 1/EA, 100/PK, 1000/CS (10PK/CS) | QUANTIFERON | ASP GLOBAL, LLC | |
| 49 | 00840216119277 | MCS1215 | 12x15 SLIDER ZIPPER BAG, SPECIMEN TRANSPORT | PROAMPAC | ASP GLOBAL, LLC | |
| 50 | 00840216118232 | LC6X9ORA | 6" X 9", 1.75MIL, ORANGE BAG, 1C, 1.5MIL CLEAR BACK POUCH W/FLAP, ZIP LOCK, 100/ 6" X 9", 1.75MIL, ORANGE BAG, 1C, 1.5MIL CLEAR BACK POUCH W/FLAP, ZIP LOCK, 100/PK, 10/PKS, 1,000/CS | LABCORP | ASP GLOBAL, LLC |