| Primary Device ID | 08426951391615 |
| NIH Device Record Key | 597142b3-3259-43d3-aa91-389b0427d9e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HemosIL D-Dimer HS 500 |
| Version Model Number | 0020500300 |
| Catalog Number | 00020500300 |
| Company DUNS | 557223252 |
| Company Name | INSTRUMENTATION LABORATORY COMPANY |
| 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 | 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 | 1 800-678-0710 |
| techsupport@ilww.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com | |
| Phone | 1-800-678-0710 |
| techsupport.na@werfen.com |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08426951391615 [Primary] |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-18 |
| Device Publish Date | 2019-06-10 |
| 08426951391615 | HemosIL D-Dimer HS 500 (XL) |
| 08426950485605 | HemosIL D-Dimer HS 500 |