N-MID® Osteocalcin ELISA
GUDID 05060169690516
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay Osteocalcin IVD, kit, chemiluminescent immunoassay| Primary Device ID | 05060169690516 |
| NIH Device Record Key | c6b0ea9e-d25c-4137-bcd3-3d6a52ad6626 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N-MID® Osteocalcin ELISA |
| Version Model Number | AC-11F1 |
| 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 |
Customer Support Contacts
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060169690516 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K003609
FDA Product Code
| NEO | System, Test, Osteocalcin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-01 |
Devices Manufactured by IMMUNODIAGNOSTIC SYSTEMS LIMITED
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| 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 |
Trademark Results [N-MID]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 N-MID 75232815 2183519 Live/Registered |
IMMUNODIAGNOSTIC SYSTEMS LTD. 1997-01-29 |
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