| Primary Device ID | G5229023901 |
| NIH Device Record Key | 1cc52cf1-21e0-4e96-9866-3a706725759c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANA/HEp-2 IgG IFA 120 Test |
| Version Model Number | 902390 |
| Company DUNS | 147827216 |
| Company Name | Hemagen Diagnostics, 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 | true |
| Device Kit | true |
| 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 |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.com | |
| Phone | 443 367 5500 |
| customerservice@hemagen.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 |
| 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 |
|---|---|
| HIBCC | G5229023901 [Primary] |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, 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 | 2023-10-13 |
| Device Publish Date | 2023-10-05 |
| G5229021111 - Cytomegalovirus / CMV IgG IFA 96 Test | 2023-10-16 For the detection and titration of cytomegalovirus (CMV) IgG antibodies in human sera |
| G5229021121 - Cytomegalovirus / CMV IgM IFA 96 Test | 2023-10-16 For the detection and titration of cytomegalovirus (CMV) IgM antibodies in human sera |
| G5229020101 - Toxo IgG IFA 120 Test | 2023-10-13 For the detection and titration of Toxoplasma gondii IgG antibodies |
| G5229020201 - Toxo IgG IFA 204 Test | 2023-10-13 For the detection and titration of Toxoplasma gondii IgG antibodies |
| G5229020211 - Toxo IgG IFA Slide Only Kit | 2023-10-13 For the detection and titration of Toxoplasma gondii IgG antibodies |
| G5229023441 - ANA/HEp-2 IgG IFA 96 Test | 2023-10-13 For the detection and titration of anti-nuclear IgG antibodies in human sera |
| G5229023451 - ANA/HEp-2 IgG IFA 180 Test | 2023-10-13 For the detection and titration of anti-nuclear IgG antibodies in human sera |
| G5229023601 - ANA/HEp-2 IgG IFA 600 Test | 2023-10-13 For the detection and titration of anti-nuclear IgG antibodies in human sera |