| Primary Device ID | B224V551 |
| NIH Device Record Key | feed8fb9-b765-4da9-ac62-de04185df9a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VDRL Antigen Kit |
| Version Model Number | V-55 |
| Catalog Number | V-55 |
| Company DUNS | 068288943 |
| Company Name | CENOGENICS CORPORATION |
| 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 | 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 | (732) 536-6457 |
| cenogenics@verizon.net | |
| Phone | (732) 536-6457 |
| cenogenics@verizon.net |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B224V551 [Primary] |
| GMQ | Antigens, Nontreponemal, All |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-17 |
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| B224V551 - VDRL Antigen Kit | 2018-03-29VDRL Test Kit is intended for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infecti |
| B224V551 - VDRL Antigen Kit | 2018-03-29 VDRL Test Kit is intended for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced |