INCUP 10-5SPCA-386
GUDID 10694644450740
Incup with AMP/COC/OPI300/OXY/THC/SVT
AMERICAN BIO MEDICA CORPORATION
Multiple therapeutic drugs/drugs of abuse IVD, calibrator Multiple therapeutic drugs/drugs of abuse IVD, calibrator Multiple therapeutic drugs/drugs of abuse IVD, calibrator Multiple therapeutic drugs/drugs of abuse IVD, calibrator Multiple therapeutic drugs/drugs of abuse IVD, calibrator Multiple therapeutic drugs/drugs of abuse IVD, calibrator Multiple therapeutic drugs/drugs of abuse IVD, calibrator Multiple therapeutic drugs/drugs of abuse IVD, calibrator Multiple therapeutic drugs/drugs of abuse IVD, calibrator Multiple therapeutic drugs/drugs of abuse IVD, calibrator Multiple therapeutic drugs/drugs of abuse IVD, calibrator Multiple therapeutic drugs/drugs of abuse IVD, calibrator Multiple therapeutic drugs/drugs of abuse IVD, calibrator| Primary Device ID | 10694644450740 |
| NIH Device Record Key | 3067d611-1d86-412f-947d-a27f2053d1b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INCUP |
| Version Model Number | 10-5SPCA-386 |
| Catalog Number | 10-5SPCA-386 |
| Company DUNS | 966665036 |
| Company Name | AMERICAN BIO MEDICA CORPORATION |
| Device Count | 25 |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 518-758-8158 |
| customerservice@abmc.com | |
| Phone | 518-758-8158 |
| customerservice@abmc.com | |
| Phone | 518-758-8158 |
| customerservice@abmc.com | |
| Phone | 518-758-8158 |
| customerservice@abmc.com | |
| Phone | 518-758-8158 |
| customerservice@abmc.com | |
| Phone | 518-758-8158 |
| customerservice@abmc.com | |
| Phone | 518-758-8158 |
| customerservice@abmc.com | |
| Phone | 518-758-8158 |
| customerservice@abmc.com | |
| Phone | 518-758-8158 |
| customerservice@abmc.com | |
| Phone | 518-758-8158 |
| customerservice@abmc.com | |
| Phone | 518-758-8158 |
| customerservice@abmc.com | |
| Phone | 518-758-8158 |
| customerservice@abmc.com | |
| Phone | 518-758-8158 |
| customerservice@abmc.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10694644400745 [Primary] |
| GS1 | 10694644450740 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K073078
FDA Product Code
| JXN | Enzyme Immunoassay, Propoxyphene |
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 | 2021-07-02 |
| Device Publish Date | 2021-06-24 |
On-Brand Devices [INCUP]
| 10694644450726 | InCup with THC/OPI300/METH/BZO/MDMA/COC/BAR |
| 10694644450733 | 6 P InCup/5P+Meth opi 300 |
| 10694644450740 | Incup with AMP/COC/OPI300/OXY/THC/SVT |
Trademark Results [INCUP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INCUP 88930793 not registered Live/Pending |
Slayton, Brandon S 2020-05-23 |
 INCUP 76616472 3048015 Live/Registered |
AMERICAN BIO MEDICA 2004-10-13 |
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