FDA UDI
In Commercial Distribution
🇺🇸 United States
Hema-Chek® Developer
DI: 00630414538396
·
Model: 10313614
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Hema-Chek® Developer
- Primary DI
- 00630414538396
- Version / Model
- 10313614
- Catalog Number
- 2596
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- b425a465-71fa-479f-adf0-e6e1abd50a8a
Device Description
For use with the in vitro diagnostic Hema-Chek® Slide Test for the Qualitatitive Determination of Fecal Occult Blood.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 | 00630414538396 | GS1 | ||||
| Unit of Use | 00630414009407 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K830223 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from heat, strong light and open flame.
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius