| Primary Device ID | 00382904905286 |
| NIH Device Record Key | b35da8cb-382b-4601-9140-bfa9900648c7 |
| Commercial Distribution Discontinuation | 2015-08-26 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | BD PrepStain |
| Version Model Number | 490528 |
| Catalog Number | 490528 |
| Company DUNS | 103318015 |
| Company Name | TRIPATH IMAGING, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 1-800-663-8663 |
| technical_services@bd.com | |
| Phone | 1-800-663-8663 |
| technical_services@bd.com |
| Length | 53.5 Centimeter |
| Length | 53.5 Centimeter |
| Length | 53.5 Centimeter |
| Height | 54 Centimeter |
| Width | 52 Centimeter |
| Length | 53.5 Centimeter |
| 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 |
|---|---|
| GS1 | 00382904905286 [Primary] |
| MKQ | Processor, Cervical Cytology Slide, Automated |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-07-22 |
| 00382904905286 | PrepStain® Install Kit |
| 00382904905231 | PrepStain® GYN Cytology Test Kit |
| 00382904905217 | PrepStain® Density Reagent |