FDA UDI
In Commercial Distribution
🇺🇸 United States
Detector Lex-CRP
DI: 10722355001187
·
Model: CRP-50
·
IMMUNOSTICS COMPANY, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Detector Lex-CRP
- Primary DI
- 10722355001187
- Version / Model
- CRP-50
- Company Name
- IMMUNOSTICS COMPANY, INC
- Labeler DUNS
- 119214195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e2d8e151-fafd-4af0-94a3-7e063cd0e52b
Device Description
A rapid undiluted latex slide test for the detection of C-Reactive Protein
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| 61988 | C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion | 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 precipitation/immunodiffusion method. CRP is a marker associated with bacterial infection and inflammatory conditions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10722355001187 | GS1 | ||||
| Unit of Use | 80722355001186 | GS1 |
Customer Contacts
- Phone
- +1(732)918-0770
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K834390 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius