FDA UDI
In Commercial Distribution
🇺🇸 United States
Immunalysis
DI: 00840937110812
·
Model: 608OF-0100
·
IMMUNALYSIS CORP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Immunalysis
- Primary DI
- 00840937110812
- Version / Model
- 608OF-0100
- Catalog Number
- 608OF-0100
- Company Name
- IMMUNALYSIS CORP
- Labeler DUNS
- 002804244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-20
- Public Version
- 6
- Public Version Date
- 2026-04-27
- Public Version Status
- Update
- Public Device Record Key
- 93e73747-28ae-474d-bc94-99718d4692de
Device Description
SEFRIA™ PCP Oral Fluid
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
- 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 |
|---|---|---|---|---|
| LCM | Enzyme immunoassay, phencyclidine | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55745 | Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of phencyclidine (PCP) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840937110812 | GS1 |
Customer Contacts
- Phone
- +1(909)482-0840
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203489 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius