FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 20885380163576
·
Model: 1077-25EIA
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
96
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 20885380163576
- Version / Model
- 1077-25EIA
- Catalog Number
- 1077-25EIA
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 96
- Record Status
- Published
- Publish Date
- 2019-02-01
- Public Version
- 5
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 0d2dfb93-44a6-40f9-ab4c-8f0660c81702
- Distribution End Date
- 2019-07-31
Device Description
H. pylori Stool Antigen ELISA Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| LYR | Helicobacter pylori | Microbiology | 866.3110 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30825 | Helicobacter pylori antigen 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 antigens from Helicobacter pylori bacteria 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 to detect infection with H. pylori which is associated with gastroduodenal disorders such as active chronic gastritis and gastric/duodenal ulcers. 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 | 20885380163576 | GS1 | ||||
| Unit of Use | 10885380163579 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053335 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius