Liquichek 115
GUDID 00847661000150
Liquichek Anti-Sm Control, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
Sm/RNP antibody IVD, control| Primary Device ID | 00847661000150 |
| NIH Device Record Key | 4ce7bc81-59f5-4adb-ad9c-cd265f013736 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Liquichek |
| Version Model Number | 115 |
| Catalog Number | 115 |
| Company DUNS | 051624070 |
| Company Name | BIO-RAD LABORATORIES, 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847661000150 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K024219
FDA Product Code
| LKP | ANTI-SM ANTIBODY, ANTIGEN AND CONTROL |
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 | 2020-01-23 |
| Device Publish Date | 2016-09-12 |
On-Brand Devices [Liquichek]
| 00847661005063 | Liquichek Spinal Fluid Control Bilevel MiniPak (A human based assayed spinal fluid control.) |
| 00847661005056 | Liquichek Spinal Fluid Control Level 2 (A human based assayed spinal fluid control.) |
| 00847661005049 | Liquichek Spinal Fluid Control Level 1 (A human based assayed spinal fluid control.) |
| 00847661004981 | Liquichek Reticulocyte Control (C) Trilevel MiniPak (An assayed reticulocyte control.) |
| 00847661004974 | Liquichek Reticulocyte Control (C) Level 3 (An assayed reticulocyte control.) |
| 00847661004967 | Liquichek Reticulocyte Control (C) Level 2 (An assayed reticulocyte control.) |
| 00847661004950 | Liquichek Reticulocyte Control (C) Level 1 (An assayed reticulocyte control.) |
| 00847661004943 | Liquichek Hematology-16T Control Trilevel MiniPak (An assayed hematology control.) |
| 00847661004936 | Liquichek Hematology-16T Control Trilevel (An assayed hematology control.) |
| 00847661004929 | Liquichek Hematology Control (A) High (An assayed hematology control.) |
| 00847661004912 | Liquichek Hematology Control (A) Normal (An assayed hematology control.) |
| 00847661004905 | Liquichek Hematology Control (A) Low (An assayed hematology control.) |
| 00847661004899 | Liquichek Hematology Control (A) Trilevel MiniPak (An assayed hematology control.) |
| 00847661004882 | Liquichek Hematology Control (A) Trilevel (An assayed hematology control.) |
| 00847661004875 | Liquichek Reticulocyte Control (A) Bilevel MiniPak (An assayed reticulocyte control.) |
| 00847661004868 | Liquichek Reticulocyte Control (A) Level 2 (An assayed reticulocyte control.) |
| 00847661004851 | Liquichek Reticulocyte Control (A) Level 1 (An assayed reticulocyte control.) |
| 00847661004844 | Liquichek Urine Toxicology Control Level S2O Low Opiate MiniPak (A human urine drugs of abuse co |
| 00847661004837 | Liquichek Urine Toxicology Control Level S2O Low Opiate (A human urine drugs of abuse control.) |
| 00847661004820 | Liquichek Urine Toxicology Control Level S2O MiniPak (A human urine drugs of abuse control.) |
| 00847661004813 | Liquichek Urine Toxicology Control Level S2O (A human urine drugs of abuse control.) |
| 00847661004806 | Liquichek Urine Toxicology Control Level S1O MiniPak (A human urine drugs of abuse control.) |
| 00847661004790 | Liquichek Urine Toxicology Control Level S1O (A human urine drugs of abuse control.) |
| 00847661004691 | Liquichek Urine Toxicology Control Level S1O Low Opiate MiniPak (A human urine drugs of abuse co |
| 00847661004677 | Liquichek Urine Toxicology Control Level S1O Low Opiate (A human urine drugs of abuse control.) |
| 00847661004639 | Liquichek Homocysteine Control MiniPak (A human serum assayed homocysteine control.) |
| 00847661004622 | Liquichek Homocysteine Control Level 3 (A human serum assayed homocysteine control.) |
| 00847661004615 | Liquichek Homocysteine Control Level 2 (A human serum assayed homocysteine control.) |
| 00847661004608 | Liquichek Homocysteine Control Level 1 (A human serum assayed homocysteine control.) |
| 00847661004516 | Liquichek D-dimer Control MiniPak (A processed human plasma assayed D-dimer control.) |
| 00847661004509 | Liquichek D-dimer Control Level 3 (A processed human plasma assayed D-dimer control.) |
| 00847661004493 | Liquichek D-dimer Control Level 2 (A processed human plasma assayed D-dimer control.) |
| 00847661004486 | Liquichek D-dimer Control Level 1 (A processed human plasma assayed D-dimer control.) |
| 00847661004479 | Liquichek D-dimer Control Level Low (A processed human plasma assayed D-dimer control.) |
| 00847661004301 | Liquichek Diabetes Control Trilevel MiniPak (A human whole blood assayed diabetes control.) |
| 00847661004295 | Liquichek Diabetes Control Level 3 (A human whole blood assayed diabetes control.) |
| 00847661004288 | Liquichek Diabetes Control Level 2 (A human whole blood assayed diabetes control.) |
| 00847661004271 | Liquichek Diabetes Control Level 1 (A human whole blood assayed diabetes control.) |
| 00847661004264 | Liquichek Cardiac Markers Plus Control LT Level 1C MiniPak (A human serum assayed cardiac marker |
| 00847661004257 | Liquichek Cardiac Markers Plus Control LT Level 1B MiniPak (A human serum assayed cardiac marker |
| 00847661004233 | Liquichek Cardiac Markers Plus Control LT Level 1A MiniPak (A human serum assayed cardiac marker |
| 00847661004226 | Liquichek Cardiac Markers Plus Control LT Level 3 MiniPak (A human serum assayed cardiac markers |
| 00847661004219 | Liquichek Cardiac Markers Plus Control LT Level 2 MiniPak (A human serum assayed cardiac markers |
| 00847661004202 | Liquichek Cardiac Markers Plus Control LT Level 1 MiniPak (A human serum assayed cardiac markers |
| 00847661004196 | Liquichek Cardiac Markers Plus Control LT Level 1C (A human serum assayed cardiac markers contro |
| 00847661004189 | Liquichek Cardiac Markers Plus Control LT Level 1B (A human serum assayed cardiac markers contro |
| 00847661004172 | Liquichek Cardiac Markers Plus Control LT Level 1A (A human serum assayed cardiac markers contro |
| 00847661004165 | Liquichek Cardiac Markers Plus Control LT Trilevel MiniPak (A human serum assayed cardiac marker |
| 00847661004158 | Liquichek Cardiac Markers Plus Control LT Level 3 (A human serum assayed cardiac markers control |
| 00847661004141 | Liquichek Cardiac Markers Plus Control LT Level 2 (A human serum assayed cardiac markers control |
Trademark Results [Liquichek]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIQUICHEK 74457239 not registered Dead/Abandoned |
Drew Chemical Corporation 1993-11-09 |
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