FDA UDI
In Commercial Distribution
🇺🇸 United States
Immunalysis
DI: 00840937110690
·
Model: 10034-5
·
IMMUNALYSIS CORP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Immunalysis
- Primary DI
- 00840937110690
- Version / Model
- 10034-5
- Catalog Number
- 10034-5
- Company Name
- IMMUNALYSIS CORP
- Labeler DUNS
- 002804244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-24
- Public Version
- 6
- Public Version Date
- 2026-04-28
- Public Version Status
- Update
- Public Device Record Key
- c8f14027-d599-4d2d-8aca-d6ed39caa477
Device Description
Ethyl Glucuronide Urine Calibrator 4
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| DLJ | Calibrators, drug specific | Clinical Toxicology | 862.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60666 | Ethyl glucuronide (EtG) 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 ethyl glucuronide (EtG), a metabolite of ethanol alcohol (ETOH), in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840937110690 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius