| Primary Device ID | 05060169691322 |
| NIH Device Record Key | 2053489b-0915-467f-a1c1-b63ef2deb756 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IDS SHBG |
| Version Model Number | IS-5600 |
| Company DUNS | 494268600 |
| Company Name | IMMUNODIAGNOSTIC SYSTEMS LIMITED |
| 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 | 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 | +4401915190660 |
| techsupport.uk@idsplc.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060169691322 [Primary] |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-04 |
| Device Publish Date | 2019-09-26 |
| 05060169695986 - IDS Beta CrossLaps® (CTX-I) | 2024-01-11 |
| 05060169696013 - IDS Beta CrossLaps® (CTX-I) Calibrator Set | 2024-01-11 |
| 05060169696051 - IDS Beta CrossLaps® (CTX-I) Control Set | 2024-01-11 |
| 05060169696457 - IDS ACTH II | 2023-08-31 |
| 05060169696495 - IDS ACTH II Calibrator Set | 2023-08-31 |
| 05060169696532 - IDS ACTH II Control Set | 2023-08-31 |
| 05060169691148 - IDS-iSYS SDSpeed Calc | 2023-07-05 |
| 05060169691261 - IDS Androstenedione | 2023-07-05 |