FDA UDI
In Commercial Distribution
🇺🇸 United States
COMPLIANCE GOLD FECAL OCCULT BLOOD TEST – ER, 50 TRI-SLIDES
DI: 00695684742522
·
Model: 74252
·
GERMAINE LABORATORIES, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- COMPLIANCE GOLD FECAL OCCULT BLOOD TEST – ER, 50 TRI-SLIDES
- Primary DI
- 00695684742522
- Version / Model
- 74252
- Company Name
- GERMAINE LABORATORIES, INC
- Labeler DUNS
- 176458115
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-05-17
- Public Version
- 3
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- c638e37c-a67b-499d-96e2-e9d56c2f8ba9
Device Description
Triple slide patient take home version of a rapid test for the qualitative detection of occult blood in stool specimens. Full Compliance features include Pre-Paid postage return envelops, compliance monitoring reminders, return labels.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| KHE | Reagent, Occult Blood | Hematology | 864.6550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54531 | Faecal occult blood IVD, kit, rapid colorimetric, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of stool (faeces) for occult blood (haemoglobin) within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly 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 | 00695684742522 | GS1 | ||||
| Unit of Use | 00695684742521 | GS1 |