| Primary Device ID | 10814434020292 |
| NIH Device Record Key | 61dc49f5-ce7c-4280-ba37-3ea4c4e1d6d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Getinge Assure AccuFast Biological Test Pack with 5 Controls |
| Version Model Number | 61301606638 |
| Catalog Number | 61301606638 |
| Company DUNS | 622223196 |
| Company Name | STERITEC PRODUCT MFG. CO., 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 | 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 |
| Storage Environment Temperature | Between 10 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 38 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814434020295 [Primary] |
| GS1 | 10814434020292 [Package] Contains: 00814434020295 Package: Case [25 Units] In Commercial Distribution |
| FRC | Indicator, Biological Sterilization Process |
| 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 | 2016-09-23 |