Primary Device ID | 10758750008445 |
NIH Device Record Key | e6a3cc93-808e-49b9-a5f3-5b50d6d6d84e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VITROS |
Version Model Number | 1113596 |
Catalog Number | 1113596 |
Company DUNS | 215865786 |
Company Name | ORTHO CLINICAL DIAGNOSTICS |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 10758750008445 [Primary] |
GS1 | 20758750008442 [Package] Package: Case [30 Units] In Commercial Distribution |
JIT | CALIBRATOR, SECONDARY |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2023-04-26 |
Device Publish Date | 2016-08-26 |
10758750002801 | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack |
10758750002795 | VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack |
10758750002788 | VITROS Immunodiagnostic Products Anti-HBs Reagent Pack |
10758750002771 | VITROS Immunodiagnostic Products Anti-HBc Reagent Pack |
10758750002764 | VITROS Immunodiagnostic Products HBsAg Reagent Pack |
10758750001699 | VITROS Immunodiagnostic Products Anti-HBs Calibrator |
10758750001682 | VITROS Immunodiagnostic Products Anti-HBs Reagent Pack |
10758750001538 | VITROS Immunodiagnostic Products Anti-HIV 1+2 Calibrator |
10758750001521 | VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack |
10758750001453 | VITROS Immunodiagnostic Products HBeAg Calibrator |
10758750001446 | VITROS Immunodiagnostic Products HBeAg Reagent Pack |
10758750001439 | VITROS Immunodiagnostic Products Anti-HBe Calibrator |
10758750001422 | VITROS Immunodiagnostic Products Anti-HBe Reagent Pack |
10758750001224 | VITROS Immunodiagnostic Products Anti-HBc Calibrator |
10758750001217 | VITROS Immunodiagnostic Products Anti-HBc Reagent Pack |
10758750001194 | VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator |
10758750001187 | VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack |
10758750001101 | VITROS Immunodiagnostic Products Anti-HCV Calibrator |
10758750001095 | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack |
10758750001088 | VITROS Immunodiagnostic Products HBsAg Confirmatory Kit |
10758750001071 | VITROS Immunodiagnostic Products HBsAg Calibrator |
10758750001064 | VITROS Immunodiagnostic Products HBsAg Reagent Pack |
10758750031597 | VITROS Immunodiagnostic Products HIV Combo Calibrator |
10758750031580 | VITROS Immunodiagnostic Products HIV Combo Reagent Pack |
10758750006267 | VITROS Immunodiagnostic Products Intact PTH Reagent Pack |
10758750006250 | VITROS Immunodiagnostic Products Intact PTH Calibrators |
10758750001309 | VITROS Immunodiagnostic Products PSA Reagent Pack |
10758750000319 | VITROS Immunodiagnostic Products PSA Calibrators |
10758750009077 | VITROS Immunodiagnostic Products Testosterone Reagent Pack |
10758750008902 | VITROS Immunodiagnostic Products LH Reagent Pack |
10758750006243 | VITROS Immunodiagnostic Products Intact PTH Range Verifier |
10758750006236 | VITROS Immunodiagnostic Products Intact PTH Controls |
10758750005017 | VITROS Immunodiagnostic Products Estradiol Reagent Pack |
10758750001156 | VITROS Immunodiagnostic Products Anti-HCV Controls |
10758750001149 | VITROS Immunodiagnostic Products HBsAg Controls |
10758750000845 | VITROS Immunodiagnostic Products Testosterone Range Verifiers |
10758750000814 | VITROS Immunodiagnostic Products Estradiol Range Verifiers |
10758750000777 | VITROS Immunodiagnostic Products Prolactin Range Verifiers |
10758750000760 | VITROS Immunodiagnostic Products FSH Range Verifiers |
10758750000753 | VITROS Immunodiagnostic Products LH Range Verifiers |
10758750000500 | VITROS Immunodiagnostic Products NTx Reagent Pack |
10758750000333 | VITROS Immunodiagnostic Products Progesterone Reagent Pack |
10758750000302 | VITROS Immunodiagnostic Products FSH Reagent Pack |
10758750000111 | VITROS Immunodiagnostic Products Prolactin Reagent Pack |
10758750009411 | VITROS Immunodiagnostic Products Anemia Controls |
10758750009053 | VITROS Immunodiagnostic Products Metabolism Controls |
10758750009015 | VITROS Immunodiagnostic Products Total Thyroid Controls |
10758750008803 | VITROS Immunodiagnostic Products Free Thyroid Controls |
10758750008322 | VITROS Immunodiagnostic Products RE Controls |
10758750002528 | VITROS Immunodiagnostic Products Troponin I ES Range Verifiers |
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 |