FDA UDI
In Commercial Distribution
🇺🇸 United States
Berichrom Antithrombin III (A)
DI: 00630414639444
·
Model: 10873898
·
Siemens Healthcare Diagnostics Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Berichrom Antithrombin III (A)
- Primary DI
- 00630414639444
- Version / Model
- 10873898
- Catalog Number
- 10873898
- Company Name
- Siemens Healthcare Diagnostics Products GmbH
- Labeler DUNS
- 388240673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-25
- Public Version
- 1
- Public Version Date
- 2024-04-02
- Public Version Status
- New
- Public Device Record Key
- 0b8bbb62-fd6b-462d-877e-567cb9760312
Device Description
Determination of the functional activity of antithrombin III (AT III) in human plasma
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 |
|---|---|---|---|---|
| JPE | ANTITHROMBIN III, TWO STAGE CLOTTING TIME ASSAY | Hematology | 864.7060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56155 | Antithrombin III (ATIII) IVD, kit, chromogenic | A collection of reagents and other associated materials intended to be used for the quantitative measurement of antithrombin III (ATIII) in a clinical specimen, using a chromogenic method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414639444 | GS1 |
Customer Contacts
- Phone
- +1(800)242-3233
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K933125 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius