| Primary Device ID | 00816879025026 |
| NIH Device Record Key | 3d3b8d70-b275-4b26-bf46-282d7eb52162 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NOVEOS House Dust - Greer |
| Version Model Number | H001 |
| Catalog Number | 8633810 |
| Company DUNS | 010558476 |
| Company Name | HYCOR BIOMEDICAL LLC |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com | |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com | |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com | |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com | |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com | |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com | |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com | |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com | |
| Phone | 800-382-2527 |
| Customerservices-us@hycorbiomedical.com |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00816879025026 [Primary] |
| PUW | System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-03 |
| Device Publish Date | 2025-06-25 |
| 00816879025026 | H001 |
| 00816879029963 | H001 |