Bio-trol BIO-N5
GUDID 00810042683082
BIO-TROL, Level N5 Positive, 10x5mL Pack
BIOCHEMICAL DIAGNOSTICS INC
Multiple drugs of abuse IVD, control| Primary Device ID | 00810042683082 |
| NIH Device Record Key | 8c062530-b742-4346-b5a5-b34fcd204060 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bio-trol |
| Version Model Number | BIO-N5 |
| Catalog Number | BIO-N5 |
| Company DUNS | 028007698 |
| Company Name | BIOCHEMICAL DIAGNOSTICS INC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810042683082 [Primary] |
FDA Product Code
| DIF | Drug Mixture Control Materials |
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 | 2021-06-23 |
| Device Publish Date | 2021-06-15 |
On-Brand Devices [Bio-trol]
| 00810042681040 | BIO-TROL, LEVEL P2 POS POTUS |
| 00810042681033 | BIO-TROL, LEVEL N NEG POTUS |
| 00810042683082 | BIO-TROL, Level N5 Positive, 10x5mL Pack |
| 00810042683068 | BIO-TROL, Level P3 Positive, 10x5mL Pack |
Trademark Results [Bio-trol]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIO-TROL 74358637 1828755 Dead/Cancelled |
Betz Laboratories, Inc. 1993-02-11 |
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