| 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 | 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) |
| 9 | 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) |
| 10 | 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. | NNK | Container, Specimen Mailer And Storage, Non-Sterile | 1 | LetsGetChecked Stool Sample Collection Kit |
| 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 | 05060147022339 | 1 | The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is t The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collecting specimens from patients receiving ELAPRASE® or VPRIV® commercial therapy for the treatment of Hunter syndrome and Gaucher. | Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient | SHIRE HUMAN GENETIC THERAPIES, INC. | |
| 2 | G229RENX30110001 | RENX-3011000 | RENX-30110002 | Whole blood collection convenience kit for KidneyIntelX | KidneyIntelX Blood Collection Convenience Kit | RENALYTIX AI, INC. |
| 3 | 04038917398763 | 51.5100.100 | 51.5100.100 | S-Monovette® POC Collect Kit | S-Monovette® POC Collect Kit | SARSTEDT, INC. |
| 4 | 00860006434588 | K1016-02 | Tasso+ convenience kit allows self-collection of a capillary blood sample that i Tasso+ convenience kit allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis. | Tasso+ Convenience Kit | TASSO, INC | |
| 5 | 00860006434571 | K1016-01 | Tasso+ convenience kit allows self-collection of a capillary blood sample that i Tasso+ convenience kit allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis. | Tasso+ Convenience Kit | TASSO, INC | |
| 6 | 00860006434564 | K1016-03 | Tasso+ convenience kit allows self-collection of a capillary blood sample that i Tasso+ convenience kit allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis. | Tasso+ Convenience Kit | TASSO, INC | |
| 7 | 00860006434557 | K1016-04 | Tasso+ convenience kit allows self-collection of a capillary blood sample that i Tasso+ convenience kit allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis. | Tasso+ Convenience Kit | TASSO, INC | |
| 8 | 00860006434533 | K1011-04 | Tasso+ allows self-collection of a capillary blood sample that is shipped to an Tasso+ allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis. | Tasso+ Convenience Kit | TASSO, INC | |
| 9 | 00860006434526 | K1011-01 | Tasso+ allows self-collection of a capillary blood sample that is shipped to an Tasso+ allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis. | Tasso+ Convenience Kit | TASSO, INC | |
| 10 | 00860006434519 | K1011-03 | Tasso+ allows self-collection of a capillary blood sample that is shipped to an Tasso+ allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis. | Tasso+ Convenience Kit | TASSO, INC | |
| 11 | 00860006434502 | K1011-02 | Tasso+ allows self-collection of a capillary blood sample that is shipped to an Tasso+ allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis. | Tasso+ Convenience Kit | TASSO, INC | |
| 12 | 00856820008005 | IVD-1-Chek | IVD-1-Chek | Capillary blood collection convenience kit | IBSchek | COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC. |
| 13 | 00850038691042 | K1019-04 | Tasso+ Convenience Kit | TASSO, INC | ||
| 14 | 00850038691035 | K1019-03 | Tasso+ Convenience Kit | TASSO, INC | ||
| 15 | 00850038691028 | K1019-02 | Tasso+ Convenience Kit | TASSO, INC | ||
| 16 | 00850038691011 | K1019-01 | Tasso+ Convenience Kit | TASSO, INC | ||
| 17 | 00850037506170 | N/A | The Blood Collection Kit is intended to provide a way to collect and transport v The Blood Collection Kit is intended to provide a way to collect and transport venous blood samples to a biobanking facility. The Blood Collection Kit contains blood specimen collection devices and associated materials necessary to transport the samples to a biobanking facility. This includes two BD 10.0mL K2 EDTA (K2E) Plus Blood Collection Tubes (366643) and one VonSeal® 95kPA Biohazard Specimen Bag. | Blood Collection Kit | VERICEL CORPORATION | |
| 18 | 00850035498385 | TN30MLSINGLE | F5PG014.02 | 30 ml Blood Draw Kits | Progen PRP Advantage | BELLUS MEDICAL, LLC |
| 19 | 00850035498378 | TN15MLSINGLE | F5PG013.02 | 15 mL Blood Draw Kit - Single | Progen PRP Advantage | BELLUS MEDICAL, LLC |
| 20 | 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. | LetsGetChecked Blood Sample Collection Kit (TRFNUS+) | PRIVAPATH DIAGNOSTICS LIMITED |
| 21 | 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. | LetsGetChecked Blood Sample Collection Kit (TRFN) | PRIVAPATH DIAGNOSTICS LIMITED |
| 22 | 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. | LetsGetChecked Blood Sample Collection Kit (MHTB) | PRIVAPATH DIAGNOSTICS LIMITED |
| 23 | 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. | LetsGetChecked Blood Sample Collection Kit (FOLT) | PRIVAPATH DIAGNOSTICS LIMITED |
| 24 | 00817617021294 | 8600-01209 | 8600-01209 | *CUSTOM* Mt Carmel Stroke Kit | Curaplex | BOUND TREE MEDICAL, LLC |
| 25 | 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 | LetsGetChecked Blood Sample Collection Kit (TRFN) | PRIVAPATH DIAGNOSTICS LIMITED |
| 26 | 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. | LetsGetChecked Blood Sample Collection Kit (MHTB) | PRIVAPATH DIAGNOSTICS LIMITED |
| 27 | 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 | LetsGetChecked Blood Sample Collection Kit (HPTT) | PRIVAPATH DIAGNOSTICS LIMITED |
| 28 | 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. | LetsGetChecked Blood Sample Collection Kit (FMHM) | PRIVAPATH DIAGNOSTICS LIMITED |
| 29 | M752F5PG014020 | F5PG014.02 | STRADIS HEALTHCARE | STRADIS MEDICAL, LLC | ||
| 30 | M752F5PG013020 | F5PG013.02 | STRADIS HEALTHCARE | STRADIS MEDICAL, LLC | ||
| 31 | M752777778888040 | 77777888804 | HOME CONVENIENCE KIT FOR REDUCING MENOPAUSE SYMPTOMS | FERTILITY HCG IM KIT | STRADIS MEDICAL LLC | |
| 32 | 10888439579550 | SBACGCBRIB | SBACGCBRIB | CLSD SYSTEM BLOOD | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 33 | M7525252501 | 525-250 | 525-250 PRP Cup & 2 Syringes | Stradis | STRADIS MEDICAL, LLC | |
| 34 | M7525252500 | 525-250 | 525-250 PRP Cup & 2 Syringes | Stradis | STRADIS MEDICAL, LLC | |
| 35 | M7525113900 | 511390 | Pen Needle Kit | Stradis Medical, LLC. | STRADIS MEDICAL LLC | |
| 36 | M7525113890 | 511389 | Pen Needle Kit | Stradis Medical, LLC. | STRADIS MEDICAL LLC | |
| 37 | 10195594667641 | SAN51ABUSA | SAN51ABUSA | UNQ ARTERIAL BLOOD GAS LINE PK | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |