| Primary Device ID | 04987481164413 |
| NIH Device Record Key | 3cd316f9-b52e-4ff2-814b-e50e606b8c49 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | uTASWako DCP |
| Version Model Number | 995-60701 |
| Catalog Number | 995-60701 |
| Company DUNS | 690598875 |
| Company Name | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com | |
| Phone | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com | |
| Phone | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com | |
| Phone | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com | |
| Phone | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com | |
| Phone | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com | |
| Phone | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com | |
| Phone | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com | |
| Phone | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com | |
| Phone | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com | |
| Phone | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com | |
| Phone | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com | |
| Phone | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com | |
| Phone | 781-323-5300 |
| fmsuregulatoryaffairs@fujifilm.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856626006120 [Previous] |
| GS1 | 04987481164413 [Primary] |
| OAU | Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-02 |
| Device Publish Date | 2020-10-23 |
| 04987481164666 - Autokit Micro Albumin | 2021-08-09 In-Vitro Diagnostic Use |
| 04987481164642 - NEFA Linearity Material | 2021-06-09 In-Vitro Diagnostic Use |
| 04987481164659 - Complement Control | 2021-06-09 In-Vitro Diagnostic Use |
| 04987481164673 - Autokit Micro Albumin Control Set | 2021-06-09 In-Vitro Diagnostic Use |
| 04987481164536 - L-Type LDL-C Reagent 1 | 2021-06-09 In-Vitro Diagnostic Use |
| 04987481164543 - L-Type LDL-C Reagent 2 | 2021-06-09 In-Vitro Diagnostic Use |
| 04987481164604 - HR Series NEFA-HR(2) Color Reagent A | 2021-06-09 In-Vitro Diagnostic Use |
| 04987481164611 - HR Series NEFA-HR(2) Solvent A | 2021-06-09 In-Vitro Diagnostic Use |