AccuSign® DOA 8 card DOA-280-25-04
GUDID 10743816000457
AccuSign® DOA 8 T/O/C/A//BZ/BA/TC/P card; 25 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical| Primary Device ID | 10743816000457 |
| NIH Device Record Key | 41ea296c-c11e-4960-9f9d-08371863764e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccuSign® DOA 8 card |
| Version Model Number | DOA-280-25-04 |
| Catalog Number | DOA-280-25-04 |
| Company DUNS | 362917692 |
| Company Name | PRINCETON BIOMEDITECH 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 | 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 |
Customer Support Contacts
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com | |
| Phone | 7322741000 |
| info@pbmc.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10743816000457 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K991078
FDA Product Code
| LCM | Enzyme Immunoassay, Phencyclidine |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-05-24 |
| Device Publish Date | 2016-09-23 |
Devices Manufactured by PRINCETON BIOMEDITECH CORPORATION
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| 10743816001638 - Status™ COVID-19 Antigen Rapid Test for Home Use | 2023-10-30 Status™ COVID-19 Antigen Rapid Test for Home Use, 2 Test Kit |
| 10743816001645 - Status™ COVID-19 Antigen Rapid Test for Home Use | 2023-10-30 Status™ COVID-19 Antigen for Home Use, 25 Test Kit |
| 10743816000532 - BioSign® hCG card | 2023-07-06 BioSign® hCG card; 35 Test kit |
| 10743816000556 - Status hCG card | 2023-07-06 Status hCG card; 35 Test kit |
| 10743816000563 - Status hCG card | 2023-07-06 Status hCG card; 12 Test sample kit |
| 10743816000570 - BioSign® hCG card | 2023-07-06 BioSign® hCG card; 35 Test kit; CE |
| 10743816000587 - BioSign® hCG card | 2023-07-06 BioSign® hCG card; 10 Test kit; CE |
Trademark Results [AccuSign]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUSIGN 74639698 1997637 Live/Registered |
Princeton BioMeditech Corporation 1995-03-01 |
 ACCUSIGN 73691298 1497239 Live/Registered |
PHILLIPS, ROD 1987-10-23 |
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