ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 1000
GUDID 00816784020963
ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 1000
SERACARE LIFE SCIENCES, INC.
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control| Primary Device ID | 00816784020963 |
| NIH Device Record Key | 647a69f3-2a65-44c6-944c-a650dd2749d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 1000 |
| Version Model Number | 2015-0222 |
| Company DUNS | 106267123 |
| Company Name | SERACARE LIFE SCIENCES, INC. |
| 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 | true |
| 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 |
Operating and Storage Conditions
| 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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816784020963 [Primary] |
FDA Product Code
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-11 |
| Device Publish Date | 2020-12-03 |
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Trademark Results [ACCURUN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCURUN 90099182 not registered Live/Pending |
AccuRun LLC 2020-08-07 |
 ACCURUN 75198245 2109153 Live/Registered |
SERACARE LIFE SCIENCES, INC. 1996-11-04 |
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