Monobind AccuLite Folate CLIA Kit -192 Wells
- Primary DI
- 00816870022017
- Brand
- Monobind AccuLite Folate CLIA Kit -192 Wells
- Company
- MONOBIND, INC.
- Model
- 7575-300
- Catalog number
- 7575-300B
- Published
- 2019-02-11
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| CGN | ACID, FOLIC, RADIOIMMUNOASSAY |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| CGN | Acid, Folic, Radioimmunoassay | Clinical Chemistry | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00816870022017 | Primary | GS1 | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of folate (vitamin B9) in a clinical specimen, using a chemiluminescent immunoassay method. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Width | 7.75 | Inch |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Handling Environment Temperature |
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(949)951-2665 | info@monobind.com |
Regulatory Flags
- DUNS number
- 083155515
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00816870020334 | Monobind AccuBind Folate ELISA Kit - 192 Wells | MONOBIND, INC. | CGN | 2019-02-11 |
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| 00817830022597 | SimulTRAC-SNB Vitamin B12/Folate 125I RIA Kit | MP BIOMEDICALS, LLC | CGN | 2017-01-09 |
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