| Primary Device ID | 05055273219951 |
| NIH Device Record Key | b990b7a1-a1fe-4a65-be48-652c828d0459 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ESSENTIAL PACKAGE SAMPLE COLLECTION KIT (USA) |
| Version Model Number | SCK10684 |
| Catalog Number | SCK10684 |
| Company DUNS | 227530649 |
| Company Name | RANDOX LABORATORIES LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com | |
| Phone | +1 304 728 2890 |
| customersupportusa@randox.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273219951 [Primary] |
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-07 |
| Device Publish Date | 2024-01-30 |
| 05055273210101 - Liquid Immunoassay Control – Level 1 (IA CONTROL 1) | 2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V |
| 05055273210118 - LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2) | 2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V |
| 05055273210125 - LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3) | 2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V |
| 05055273219814 - PTH CONTROL LEVEL 1 (PTH CONTROL 1) | 2025-04-01 The PTH Control Level 1 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr |
| 05055273219821 - PTH CONTROL LEVEL 2 (PTH CONTROL 2) | 2025-04-01 The PTH Control Level 2 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr |
| 05055273219838 - PTH CONTROL LEVEL 3 (PTH CONTROL 3) | 2025-04-01 The PTH Control Level 3 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr |
| 05055273219043 - LIQUID CARDIAC CONTROL 1 | 2025-03-31 The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, Hig |
| 05055273219050 - LIQUID CARDIAC CONTROL 2 | 2025-03-31 The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, Hig |