FDA UDI
In Commercial Distribution
🇺🇸 United States
Detector Cept-D Polyclonal
DI: 10722355001446
·
Model: 43100
·
IMMUNOSTICS COMPANY, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Detector Cept-D Polyclonal
- Primary DI
- 10722355001446
- Version / Model
- 43100
- Company Name
- IMMUNOSTICS COMPANY, INC
- Labeler DUNS
- 119214195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 4
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- 914e920a-a3f9-4dbe-8390-3a89c0ccdab6
Device Description
A rapid latex inhibition slide test for the detection of hCG in urine
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 |
|---|---|---|---|---|
| JHJ | AGGLUTINATION METHOD, HUMAN CHORIONIC GONADOTROPIN | Clinical Chemistry | 862.1155 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57299 | Total human chorionic gonadotropin IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10722355001446 | GS1 | ||||
| Unit of Use | 80722355001445 | GS1 |
Customer Contacts
- Phone
- +1(732)918-0770
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K842110 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius