FDA UDI
In Commercial Distribution
🇺🇸 United States
Syva® RapidTest d.a.u.® 4
DI: 00842768001307
·
Model: 10445359
·
Siemens Healthcare Diagnostics Inc.
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Syva® RapidTest d.a.u.® 4
- Primary DI
- 00842768001307
- Version / Model
- 10445359
- Catalog Number
- 6A199UL
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 005088112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 38059023-6740-425f-8cfd-5dab634bb358
Device Description
Syva® RapidTest d.a.u.® 4 THC / OPI / COC / AMP
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| DJG | ENZYME IMMUNOASSAY, OPIATES | Clinical Toxicology | 862.3650 | 2 |
| DKZ | ENZYME IMMUNOASSAY, AMPHETAMINE | Clinical Toxicology | 862.3100 | 2 |
| LDJ | ENZYME IMMUNOASSAY, CANNABINOIDS | Clinical Toxicology | 862.3870 | 2 |
| DIO | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES | Clinical Toxicology | 862.3250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46994 | Multiple drugs of abuse IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768001307 | GS1 | ||||
| Unit of Use | 00630414013923 | GS1 |
Customer Contacts
- Phone
- +1(800)227-8994
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius