FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Human Fetal Hemoglobin Test Kit
DI: 10190302005340
·
Model: HFH04
·
LIFE TECHNOLOGIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Human Fetal Hemoglobin Test Kit
- Primary DI
- 10190302005340
- Version / Model
- HFH04
- Company Name
- LIFE TECHNOLOGIES CORPORATION
- Labeler DUNS
- 080131636
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 9
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- a37e1d0a-6052-4a9a-b6a5-ad2fc542f191
- Distribution End Date
- 2022-04-27
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 |
|---|---|---|---|---|
| GHQ | STAIN, FETAL HEMOGLOBIN | Hematology | 864.7455 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54556 | Multiple solid tumour differentiation marker IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple proteins/markers associated with more than one specific tissue or solid tumour (e.g., lung, breast, ovarian, kidney, gastrointestinal, colon) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used in cancer-screening assays to help diagnostic differentiation between solid tumour types through detection of various types of proteins/markers [e.g., epithelial cell adhesion molecule (EpCAM), pan-cytokeratin (pan-CK), prostate-specific membrane antigen (PSMA), alpha-methylacyl-CoA racemase (AMACR)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190302005340 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990641 | 000 |