SABS SP3856
GUDID 05055273206289
This product is used for checking proper functioning of the sample fluid metering system as well as the photometric measuring system.
RANDOX LABORATORIES LIMITED
Optical instrument calibration/verification solution IVD| Primary Device ID | 05055273206289 |
| NIH Device Record Key | 7ec0e86e-784a-4e34-bc9a-bd3eaef850af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SABS |
| Version Model Number | SP3856 |
| Catalog Number | SP3856 |
| Company DUNS | 227530649 |
| Company Name | RANDOX LABORATORIES 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *R1 Stable on board the analyser for 30 days at approximately +10°C. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273206289 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K024014
FDA Product Code
| JJF | Analyzer, Chemistry, Micro, For Clinical Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2016-09-26 |
On-Brand Devices [SABS]
| 05055273214444 | This product is used for checking proper functioning of the sample fluid metering system as well |
| 05055273206289 | This product is used for checking proper functioning of the sample fluid metering system as well |
Trademark Results [SABS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SABS 97840104 not registered Live/Pending |
Hay Tina 2023-03-15 |
 SABS 85417223 not registered Dead/Abandoned |
KE CHIUAN TECHNOLOGY CORP. 2011-09-07 |
 SABS 78682534 3117089 Dead/Cancelled |
Strata International Group Inc. 2005-08-01 |
 SABS 73829642 not registered Dead/Abandoned |
SUMITOMO ELECTRIC INDUSTRIES, LTD. 1989-10-06 |
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