| Primary Device ID | 04562185400311 |
| NIH Device Record Key | 52e845f9-3ad4-4868-a594-dc63deeeaabd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CL AIA-PACK FSH TEST CUP |
| Version Model Number | N/A |
| Company DUNS | 690571724 |
| Company Name | TOSOH CORPORATION |
| Device Count | 3 |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04562185400311 [Unit of Use] |
| GS1 | 14562185400318 [Primary] |
| GS1 | 24562185400315 [Package] Contains: 14562185400318 Package: [20 Units] In Commercial Distribution |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-09 |
| Device Publish Date | 2025-09-01 |