| Primary Device ID | 05060169693913 |
| NIH Device Record Key | 67e9e87f-d770-4967-9169-0f1f545a5b75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IDS Top Cap Set |
| Version Model Number | IS-CAP300 |
| Company DUNS | 494268600 |
| Company Name | IMMUNODIAGNOSTIC SYSTEMS LIMITED |
| Device Count | 1 |
| 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 | 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 | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com | |
| Phone | +4401915190660 |
| techsupport.uk@idsplc.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060169693913 [Primary] |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-05 |
| Device Publish Date | 2023-06-27 |
| 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 |