K-CHECK B1555
GUDID 00860009154001
The K-Check tablet is a chromogenic reagent to be used by trained laboratory professionals to determine the qualitative /semi-quantitative presence of two Ketone bodies i.e. acetone and acetoacetic acid in Urine, Serum, Plasma or Whole blood. The test results are read visually.
Biorex Labs LLC
Acetone IVD, reagent Acetone IVD, reagent Acetone IVD, reagent Acetone IVD, reagent Acetone IVD, reagent Acetone IVD, reagent Acetone IVD, reagent Acetone IVD, reagent Acetone IVD, reagent Acetone IVD, reagent Acetone IVD, reagent Acetone IVD, reagent Acetone IVD, reagent Acetone IVD, reagent Acetone IVD, reagent| Primary Device ID | 00860009154001 |
| NIH Device Record Key | f071a292-9c7d-49e6-bd67-77f8d698dae2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-CHECK |
| Version Model Number | 1 |
| Catalog Number | B1555 |
| Company DUNS | 060975106 |
| Company Name | Biorex Labs LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com | |
| Phone | 440-824-3000 |
| info@biorexlabs.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009154001 [Primary] |
FDA Product Code
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) |
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 | 2022-12-12 |
| Device Publish Date | 2022-12-02 |
Devices Manufactured by Biorex Labs LLC
| 00860009154001 - K-CHECK | 2022-12-12The K-Check tablet is a chromogenic reagent to be used by trained laboratory professionals to determine the qualitative /semi-quantitative presence of two Ketone bodies i.e. acetone and acetoacetic acid in Urine, Serum, Plasma or Whole blood. The test results are read visually. |
| 00860009154001 - K-CHECK | 2022-12-12 The K-Check tablet is a chromogenic reagent to be used by trained laboratory professionals to determine the qualitative /semi-qu |
| 00860009154018 - DIAZO-CHEK | 2022-12-12 The DIAZO-CHEK test is used to qualitatively detect bilirubin in urine or confirm the positive results obtained by a reagent str |
| 00860009154025 - K-CHECK CONTROLS | 2022-12-12 The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy an |
Trademark Results [K-CHECK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 K-CHECK 86828189 5002376 Live/Registered |
Biorex Labs LLC 2015-11-21 |
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