| Primary Device ID | 00816870023441 |
| NIH Device Record Key | 8ae183e5-01c5-409d-a952-c39336a6aca4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PCT AccuLite CLIA Test System - 96 Wells |
| Version Model Number | 9275-300 |
| Catalog Number | 9275-300A |
| Company DUNS | 083155515 |
| Company Name | MONOBIND, 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 | 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(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com | |
| Phone | +1(949)951-2665 |
| info@monobind.com |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| Width | 7.75 Inch |
| 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 |
| 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 |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816870023441 [Primary] |
| NTM | Antigen, inflammatory response marker, sepsis |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-23 |
| Device Publish Date | 2024-09-13 |