VITROS 6800191
GUDID 10758750000630
VITROS Chemistry Products UPRO Performance Verifier II
ORTHO-CLINICAL DIAGNOSTICS, INC.
Total protein IVD, control| Primary Device ID | 10758750000630 |
| NIH Device Record Key | e748073b-e9f1-41da-a60b-9b2314b6020c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VITROS |
| Version Model Number | 6800191 |
| Catalog Number | 6800191 |
| Company DUNS | 623873044 |
| Company Name | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 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 | false |
| 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 |
Operating and Storage Conditions
| 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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10758750000630 [Primary] |
| GS1 | 20758750000637 [Package] Package: Case [100 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K964960
FDA Product Code
| JGP | LOWRY (COLORIMETRIC), TOTAL PROTEIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-08 |
| Device Publish Date | 2020-05-29 |
On-Brand Devices [VITROS]
| 10758750032105 | VITROS Chemistry Products Calibrator Kit 32 |
| 10758750031801 | VITROS XT Chemistry Products TBIL-ALKP Slides |
| 10758750031795 | VITROS XT Chemistry Products GLU-Ca Slides |
| 10758750031788 | VITROS XT Chemistry Products UREA-CREA Slides |
| 10758750031764 | VITROS XT Chemistry Products TRIG-CHOL Slides |
| 10758750030736 | VITROS Chemistry Products Calibrator Kit 31 |
| 10758750002832 | VITROS Chemistry Products Calibrator Kit 30 |
| 10758750032136 | VITROS Chemistry Products ALTV Slides |
| 10758750031108 | VITROS Chemistry Products LDHI Slides |
| 10758750009602 | VITROS Chemistry Products AMON Slides |
| 10758750009527 | VITROS Chemistry Products CHOL Slides |
| 10758750009510 | VITROS Chemistry Products LIPA Slides |
| 10758750009480 | VITROS Chemistry Products ALT Slides |
| 10758750009244 | VITROS Chemistry Products Fe Slides |
| 10758750009220 | VITROS Chemistry Products PHOS Slides |
| 10758750008957 | VITROS Chemistry Products Liquid Performance Verifier II |
| 10758750008889 | VITROS Chemistry Products TRIG Slides |
| 10758750006977 | VITROS Chemistry Products %A1c Performance Verifier II |
| 10758750006960 | VITROS Chemistry Products %A1c Performance Verifier I |
| 10758750006908 | VITROS Chemistry Products PALB Reagent |
| 10758750006878 | VITROS Chemistry Products ApoB Reagent |
| 10758750006861 | VITROS Chemistry Products ApoA1 Reagent |
| 10758750006793 | VITROS Chemistry Products dLDL Reagent |
| 10758750005208 | VITROS Chemistry Products CRP Performance Verifier I |
| 10758750005154 | VITROS Chemistry Products Isoenzyme Performance Verifier II |
| 10758750005123 | VITROS Chemistry Products Isoenzyme Performance Verifier I |
| 10758750005062 | VITROS Chemistry Products CRP Performance Verifier II |
| 10758750004959 | VITROS Chemistry Products Liquid Performance Verifier I |
| 10758750004911 | VITROS Chemistry Products LAC Slides |
| 10758750004768 | VITROS Chemistry Products TRIG Slides |
| 10758750004683 | VITROS Chemistry Products LIPA Slides |
| 10758750004638 | VITROS Chemistry Products GGT Slides |
| 10758750004577 | VITROS Chemistry Products Performance Verifier II |
| 10758750004454 | VITROS Chemistry Products LAC Slides |
| 10758750004317 | VITROS Chemistry Products Performance Verifier I |
| 10758750004225 | VITROS Chemistry Products CHE Slides |
| 10758750002825 | VITROS Chemistry Products dHDL Slides |
| 10758750002733 | VITROS Chemistry Products ASO/RF Performance Verifier II |
| 10758750002726 | VITROS Chemistry Products ASO/RF Performance Verifier I |
| 10758750002573 | VITROS Chemistry Products AAT/HPT Performance Verifier III |
| 10758750002566 | VITROS Chemistry Products AAT/HPT Performance Verifier II |
| 10758750002559 | VITROS Chemistry Products AAT/HPT Performance Verifier I |
| 10758750002306 | VITROS Chemistry Products ASO Reagent |
| 10758750001873 | VITROS Chemistry Products dTIBC Reagent |
| 10758750001668 | VITROS Chemistry Products dHDL Slides |
| 10758750001385 | VITROS Chemistry Products ApoB Performance Verifier I |
| 10758750001378 | VITROS Chemistry Products ApoA1 Performance Verifier I |
| 10758750000289 | VITROS Chemistry Products Fe Slides |
| 10758750000241 | VITROS Chemistry Products CHE Slides |
| 10758750000012 | VITROS Chemistry Products AMON Slides |
Trademark Results [VITROS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VITROS 87764891 5492323 Live/Registered |
Crimson U.S. Assets LLC 2018-01-22 |
 VITROS 87202232 5204885 Live/Registered |
Crimson U.S. Assets LLC 2016-10-13 |
 VITROS 75142862 2126793 Live/Registered |
CRIMSON U.S. ASSETS LLC 1996-07-31 |
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