FDA UDI
In Commercial Distribution
🇺🇸 United States
Monobind AccuLite AFP, hCG & uE3 VAST CLIA Kit - 480 Wells
DI: 00816870022550
·
Model: 8575-300
·
MONOBIND, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Monobind AccuLite AFP, hCG & uE3 VAST CLIA Kit - 480 Wells
- Primary DI
- 00816870022550
- Version / Model
- 8575-300
- Catalog Number
- 8575-300D
- Company Name
- MONOBIND, INC.
- Labeler DUNS
- 083155515
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-11
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- e488a71d-9d47-4d25-9981-070819d54982
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LOJ | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER | Immunology | 866.6010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54175 | Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple hormone levels in a clinical specimen using a chemiluminescent immunoassay method, in order to predict the risk of trisomy 21 (Down syndrome) as part of a first or second trimester screening assessment. Hormones assayed may include alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), pregnancy associated plasma protein A (PAPP-A), estriol and/or inhibin A. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816870022550 | GS1 |
Customer Contacts
- Phone
- +1(949)951-2665
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 12 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Handling Environment Temperature