FDA UDI
In Commercial Distribution
🇺🇸 United States
AMYLASE PLUS
DI: B800AMYLSFDB0
·
Model: AMYL+ S F DB
·
UTAK LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- AMYLASE PLUS
- Primary DI
- B800AMYLSFDB0
- Version / Model
- AMYL+ S F DB
- Catalog Number
- AMYL+ S F DB
- Company Name
- UTAK LABORATORIES, INC.
- Labeler DUNS
- 092519016
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-13
- Public Version
- 1
- Public Version Date
- 2023-12-21
- Public Version Status
- New
- Public Device Record Key
- 7e425b19-ef6c-436e-a06c-1d87e636b260
Device Description
AMYLASE PLUS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| LAS | Drug Specific Control Materials | Clinical Toxicology | 862.3280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55461 | Multiple drugs of abuse IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B800AMYLSFDB5 | HIBCC | BOX | 25 | In Commercial Distribution | |
| Primary | B800AMYLSFDB0 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -10 Degrees Celsius