| Primary Device ID | 00817302020946 |
| NIH Device Record Key | 25fc4cc4-6649-41fb-8869-adb98ee71060 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214 |
| Version Model Number | AU-214 |
| Catalog Number | AU-214 |
| Company DUNS | 962385787 |
| Company Name | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 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 |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com | |
| Phone | +1(800)471-7272 |
| ContactSales@CarolinaChemistries.com |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 25 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 60 Milliliter |
| Total Volume | 25 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 60 Milliliter |
| Total Volume | 25 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 60 Milliliter |
| Total Volume | 25 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 60 Milliliter |
| Total Volume | 25 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 60 Milliliter |
| Total Volume | 25 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 60 Milliliter |
| Total Volume | 25 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 60 Milliliter |
| Total Volume | 25 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 60 Milliliter |
| Total Volume | 25 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 60 Milliliter |
| Total Volume | 25 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 60 Milliliter |
| Total Volume | 25 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 60 Milliliter |
| Total Volume | 25 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 60 Milliliter |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable when stored at 8 to 30° C until expiration date |
| Storage Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable when stored at 8 to 30° C until expiration date |
| Storage Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable when stored at 8 to 30° C until expiration date |
| Storage Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable when stored at 8 to 30° C until expiration date |
| Storage Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable when stored at 8 to 30° C until expiration date |
| Storage Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable when stored at 8 to 30° C until expiration date |
| Storage Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable when stored at 8 to 30° C until expiration date |
| Storage Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable when stored at 8 to 30° C until expiration date |
| Storage Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable when stored at 8 to 30° C until expiration date |
| Storage Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable when stored at 8 to 30° C until expiration date |
| Storage Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable when stored at 8 to 30° C until expiration date |
| Storage Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable when stored at 8 to 30° C until expiration date |
| Storage Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817302020946 [Primary] |
| CJW | BROMCRESOL PURPLE DYE-BINDING, ALBUMIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-01 |
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| 00817302024678 - CAROLINA LIQUID CHEMISTRIES CORP.® OXIDANT REAGENT CC445 | 2022-12-12 Oxidant Reagent (CC445) |
| 00817302024654 - Caldon Biotech Aldolase Reagent | 2022-12-08 Aldolase |
| 00817302024661 - Caldon Biotech Serum Aldolase Controls | 2022-12-08 Aldolase Controls |
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| 00817302024104 - CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220 | 2022-08-29 Magnesium Arsenazo Reagent (MG) |