FDA UDI
In Commercial Distribution
🇺🇸 United States
ihcDirect® CDX2 Ab Conjugate 5mL
DI: 00850030934857
·
Model: H32047-R005
·
NOVODIAX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ihcDirect® CDX2 Ab Conjugate 5mL
- Primary DI
- 00850030934857
- Version / Model
- H32047-R005
- Catalog Number
- K32047-005
- Company Name
- NOVODIAX, INC.
- Labeler DUNS
- 965326957
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-20
- Public Version
- 1
- Public Version Date
- 2021-08-30
- Public Version Status
- New
- Public Device Record Key
- 1a3bae49-2fb2-4998-80ba-b342d66ca533
Device Description
Clone R1014
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
- 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 |
|---|---|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | Hematology | 864.1860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57332 | Homeobox protein CDX-2 IVD, kit, enzyme immunohistochemistry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of homeobox protein CDX-2, also referred to as caudal-type homeobox protein 2, in a clinical specimen, using an enzyme immunohistochemistry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850030934857 | GS1 | ||||
| Previous | 00850000596870 | GS1 |
Customer Contacts
- Phone
- 5103423043
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Milliliter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 21 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius