FDA UDI
In Commercial Distribution
🇺🇸 United States
AccuDiag™
DI: 00894175000312
·
Model: DACD310-100
·
Diagnostic Automation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AccuDiag™
- Primary DI
- 00894175000312
- Version / Model
- DACD310-100
- Catalog Number
- 310-100
- Company Name
- Diagnostic Automation, Inc.
- Labeler DUNS
- 878252071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-26
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- c7820512-38b5-4293-83e4-8c25ae2af67d
Device Description
AccuDiag™CRP Latex Test Kit C- Reactive Protein (CRP) latex slide test is used for the qualitative and semi-quantitative measurement of C-reactive protein (CRP) in human serum.
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | Immunology | 866.5270 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53705 | C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen, using a nephelometry/turbidimetry method [includes high-sensitivity CRP (hsCRP) types]. CRP is a marker associated with bacterial infection, inflammatory conditions, and cardiovascular disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00894175000312 | GS1 |
Customer Contacts
- Phone
- 8185913030
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius