| Primary Device ID | 10711234107027 |
| NIH Device Record Key | 64139268-d269-4a5f-99b1-e2d707f9efd6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | directCHECK Whole Blood Controls |
| Version Model Number | DCJAPTT-N |
| Catalog Number | DCJAPTT-N |
| Company DUNS | 079299318 |
| Company Name | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
| Device Count | 15 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00711234107020 [Unit of Use] |
| GS1 | 10711234107027 [Primary] |
| GGN | Plasma, Coagulation Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-08-31 |
| Device Publish Date | 2016-09-22 |
| 10711234540046 | Protective Sleeves |
| 10711234170243 | directCHECK ACT-LR - Normal 15/box |
| 10711234170236 | directCHECK PT - Normal 15/box |
| 10711234170229 | directCHECK ACT+ Normal 15/box |
| 10711234170175 | directCHECK Citrate APTT - Abnormal 15/box |
| 10711234107089 | directCHECK ACT-LR Abnormal 15/box |
| 10711234107072 | directCHECK Citrate PT - Normal 15/box |
| 10711234107065 | directCHECK Citrate PT - Abnormal 15/box |
| 10711234107058 | directCHECK ACT+ Abnormal 15/box |
| 10711234107041 | directCHECK PT - Abnormal 15/box |
| 10711234107034 | directCHECK APTT - Abnormal 15/box |
| 10711234107027 | directCHECK APTT- Normal 15/box |