FDA UDI
In Commercial Distribution
🇺🇸 United States
INCUP
DI: 10694644400738
·
Model: 10-6SC-030
·
AMERICAN BIO MEDICA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- INCUP
- Primary DI
- 10694644400738
- Version / Model
- 10-6SC-030
- Catalog Number
- 10-6SC-030
- Company Name
- AMERICAN BIO MEDICA CORPORATION
- Labeler DUNS
- 966665036
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-09-17
- Public Version
- 1
- Public Version Date
- 2020-09-25
- Public Version Status
- New
- Public Device Record Key
- 6017303a-398d-4704-947f-5b4f54d9b64c
Device Description
6 P InCup/5P+Meth opi 300
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LAG | High Pressure Liquid Chromatography, Methamphetamine | Clinical Toxicology | 862.3610 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55455 | Multiple therapeutic drugs/drugs of abuse IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10694644450733 | GS1 | ||||
| Primary | 10694644400738 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K073078 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit