FDA UDI
In Commercial Distribution
🇺🇸 United States
CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421
DI: 00817302021370
·
Model: AU-421
·
CAROLINA LIQUID CHEMISTRIES CORPORATION
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421
- Primary DI
- 00817302021370
- Version / Model
- AU-421
- Catalog Number
- AU-421
- Company Name
- CAROLINA LIQUID CHEMISTRIES CORPORATION
- Labeler DUNS
- 962385787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 3
- Public Version Date
- 2023-08-14
- Public Version Status
- Update
- Public Device Record Key
- 5691be36-17a1-4d32-91a3-2ce27260a043
Device Description
ETHA (Alcohol) w/ cal 2 x 625 tests
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| DNN | CALIBRATORS, ETHYL ALCOHOL | Clinical Toxicology | 862.3200 | 2 |
| DKC | ALCOHOL CONTROL MATERIALS | Clinical Toxicology | 862.3280 | 1 |
| DIC | ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD | Clinical Toxicology | 862.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55608 | Ethanol (ETOH) IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of ethyl alcohol (ETOH) in a clinical specimen, using a spectrophotometry method. It is typically used to assess for alcohol intoxication and in the management of alcoholism. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817302021370 | GS1 |
Customer Contacts
- Phone
- +1(800)471-7272
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 60 | Milliliter | |
| Total Volume | 25 | Milliliter | |
| Total Volume | 5 | Milliliter | |
| Device Size Text, specify | Kit contains 2 R1, 2 R2 bottles, 1 Calibrator and 1 package insert |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Reagent is stable when stored at 2-8° C until expiration date
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius