FDA UDI
In Commercial Distribution
🇺🇸 United States
B.R.A.H.M.S CgA II KRYPTOR
DI: 04260157632127
·
Model: 839050N
·
B.R.A.H.M.S GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- B.R.A.H.M.S CgA II KRYPTOR
- Primary DI
- 04260157632127
- Version / Model
- 839050N
- Catalog Number
- 839050N
- Company Name
- B.R.A.H.M.S GmbH
- Labeler DUNS
- 343844205
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-22
- Public Version
- 1
- Public Version Date
- 2023-10-02
- Public Version Status
- New
- Public Device Record Key
- 7bbf5760-ca30-42ab-a1d9-ffcb2e4fca52
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| QXS | Chromogranin A | Immunology | 866.6010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60603 | Chromogranin A IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of chromogranin A in a clinical specimen, using an using a fluorescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260157632127 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222251 | 000 |