| Primary Device ID | 10629009101104 |
| NIH Device Record Key | 2f010e9c-843f-4945-980b-b1f74aef36ef |
| Commercial Distribution Discontinuation | 2024-03-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | VisuCon-L Coag Screen ABN1 Plasma |
| Version Model Number | LCSAB101 |
| Company DUNS | 249373515 |
| Company Name | Affinity Biologicals Inc |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com | |
| Phone | 1-800-903-6020 |
| info@affinitybiologicals.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10629009100015 [Unit of Use] |
| GS1 | 10629009101104 [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 | 2 |
| Public Version Date | 2024-07-08 |
| Device Publish Date | 2018-10-19 |
| 10629009091108 - VisuCon-L Coag Screen N Plasma | 2024-07-08 A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES buffer and stabilizers, |
| 10629009101104 - VisuCon-L Coag Screen ABN1 Plasma | 2024-07-08A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The plasma is buffered with 0.05M HEPES buffer and stabilizers, dispensed, and lyophilized. This plasma is used for the quality control of coagulation assays (PT and APTT) in the mid-level abnormal range. |
| 10629009101104 - VisuCon-L Coag Screen ABN1 Plasma | 2024-07-08 A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The |
| 10629009111103 - VisuCon-L Coag Screen ABN2 Plasma | 2024-07-08 A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The p |
| 10629009140516 - Sheep anti-human Factor XIII Analyte Specific Reagent | 2022-10-03 The specific use of this ASR (Analyte Specific Reagent) will depend upon the end-user's application. |
| 10629009145016 - Sheep anti-human Factor XIII Analyte Specific Reagent | 2022-10-03 The specific use of this ASR (Analyte Specific Reagent) will depend upon the end user's application. |
| 10629009121102 - VisuCon-L(TM) Abnormal Control Plasma | 2019-10-30 A pool of citrated normal human plasma collected from a minimum of 20 donors, and diluted to defined concentrations. Plasma is b |
| 10629009131101 - VisuCon-L(TM) Normal Control Plasma | 2019-10-30 A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES and stabilizers, dispens |