ACCURUN® 2015-0065
GUDID 00816784020253
ACCURUN 106 Series 1000 HIV-1 Ag 3 x 5.0 mL
SERACARE LIFE SCIENCES, INC.
HIV1 antigen IVD, control| Primary Device ID | 00816784020253 |
| NIH Device Record Key | 799a2207-883b-4f8d-9f5d-4c7ff896fb85 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACCURUN® |
| Version Model Number | 2015-0065 |
| Catalog Number | 2015-0065 |
| Company DUNS | 106267123 |
| Company Name | SERACARE LIFE SCIENCES, INC. |
| 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 | false |
| 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 | false |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816784020253 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- BK990032
FDA Product Code
| MYZ | Kit, Test (Donors), For Bloodborne Pathogen |
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 | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
On-Brand Devices [ACCURUN®]
| 00816784020888 | ACCURUN 1 Series 2700 Multi-Marker Positive Control 3 x 1 mL |
| 00816784020871 | ACCURUN 1 Series 2700 Multi-Marker Positive Control 6 x 3.5 mL |
| 00816784020819 | ACCURUN 872 HPV DNA 10 x 1.0 mL Cells 10 x 1.0 mL Diluent |
| 00816784020802 | ACCURUN 315 Series 500 HIV-1 RNA 5 x 1.0 mL |
| 00816784020789 | ACCURUN 1 Series 8100 Multi-Marker 3 x 5.0 mL |
| 00816784020772 | ACCURUN 1 Series 5100 Multi-Marker 12 x 3.5 mL |
| 00816784020765 | ACCURUN 1 Series 5100 Multi-Marker Positive Control 3 x 5.0 mL |
| 00816784020710 | ACCURUN 803 NUCLEIC ACID HIV, HCV, HBV 10 x 1.2 mL |
| 00816784020703 | ACCURUN 873 HPV DNA 20 x 4.0 mL |
| 00816784020697 | ACCURUN 342 Series 700 CT/NG 10 x 1.0 mL |
| 00816784020680 | ACCURUN 342 Series 100 CT/NG 10 x 1.0 mL |
| 00816784020673 | ACCURUN 841 CT/NG 5 x 1.0 mL |
| 00816784020666 | ACCURUN 381 HPV TYPE 16 & 18 mRNA 10 x 1.0 mL - HPV Type 16 10 x 1.0 mL - HPV Type 18 |
| 00816784020659 | ACCURUN 378 Series 5000 HPV DNA 20 x 4.0 mL |
| 00816784020642 | ACCURUN 372 Series 600 HPV DNA 10 x 1.0 mL SiHa and H9 Cells 10 x 1.0 mL Diluent |
| 00816784020635 | ACCURUN 372 Series 400 10 x 0.8 mL SiHa and H9 Cells 10 x 2.0 mL Diluent |
| 00816784020628 | ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 4.0 mL |
| 00816784020611 | ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 1.2 mL |
| 00816784020604 | ACCURUN 325 Series 700 HBV DNA 5 x 4.0 mL |
| 00816784020598 | ACCURUN 325 Series 200 HBV DNA 5 x 4.0 mL |
| 00816784020581 | ACCURUN 325 Series 370 HBV DNA Positive Control 5 x 0.6 mL |
| 00816784020574 | ACCURUN 315 Series 400 HIV-1 RNA 5 x 1.0 mL |
| 00816784020567 | ACCURUN 315 Series 200 HIV-1 RNA 5 x 1.0 mL |
| 00816784020550 | ACCURUN 315 Series 150 HIV-1 RNA 10 x 1.2 mL |
| 00816784020536 | ACCURUN 305 Series 400 HCV RNA 5 x 4.0 mL |
| 00816784020529 | ACCURUN 305 Series 300 HCV RNA 5 x 1.0 mL |
| 00816784020512 | ACCURUN 305 Series 100 HCV RNA 5 x 1.0 mL |
| 00816784020505 | ACCURUN 305 Series 150 HCV RNA Positive Control 10 x 1.2 mL |
| 00816784020499 | ACCURUN 190 Anti - Trypanosoma cruzi 6 x 3.5 mL |
| 00816784020482 | ACCURUN 156 Reagin (Syphilis) 3 x 1.0 mL |
| 00816784020475 | ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 3 x 2.0 mL |
| 00816784020468 | ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 12 x 3.5 mL |
| 00816784020451 | ACCURUN 155 Series 2000 Anti-Treponema (Syphilis) 3 x 2.0 mL |
| 00816784020444 | ACCURUN 146 CMV IgM Positive Control 1 x 1.0 mL |
| 00816784020437 | ACCURUN 145 CMV IgG 1 x 1.0 mL |
| 00816784020420 | ACCURUN 141 Rubella IgM 1 x 1.0 mL |
| 00816784020413 | ACCURUN 140 Rubella IgG 1 x 5.0 mL |
| 00816784020406 | ACCURUN 136 Toxoplasma IgM 1 x 1.0 mL |
| 00816784020390 | ACCURUN 135 Toxoplasma IgG 1 x 1.0 mL |
| 00816784020383 | ACCURUN 132 Borrelia burgdorferi IgM 1 x 1.0 mL |
| 00816784020376 | ACCURUN 130 Borrelia burgdorferi IgG 1 x 1.0 mL |
| 00816784020369 | ACCURUN 127 Anti-Hepatitis Delta 1 x 1.0 mL |
| 00816784020352 | ACCURUN 125 Anti-HBs 6 x 3.5 mL |
| 00816784020345 | ACCURUN 125 Anti-HBs 1 x 5.0 mL |
| 00816784020338 | ACCURUN 121 HAV IgM 6 x 3.5 mL |
| 00816784020321 | ACCURUN 121 HAV IgM 1 x 5.0 mL |
| 00816784020314 | ACCURUN 120 HAV IgG 1 x 5.0 mL |
| 00816784020307 | ACCURUN 119 Anti-Hepatitis B e Antigen 1 x 5.0 mL |
| 00816784020291 | ACCURUN 117 Hepatitis B e Antigen 1 x 5.0 mL |
| 00816784020284 | ACCURUN 115 Hepatitis B Core IgG 1 x 5.0 mL |
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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