| Primary Device ID | 10722355001446 |
| NIH Device Record Key | 914e920a-a3f9-4dbe-8390-3a89c0ccdab6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Detector Cept-D Polyclonal |
| Version Model Number | 43100 |
| Company DUNS | 119214195 |
| Company Name | IMMUNOSTICS COMPANY, INC |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10722355001446 [Primary] |
| GS1 | 80722355001445 [Unit of Use] |
| JHJ | AGGLUTINATION METHOD, HUMAN CHORIONIC GONADOTROPIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-07-06 |
| Device Publish Date | 2016-09-20 |
| 10722355001293 - Detector hCG | 2023-07-06 For the qualitative detection of hCG in urine |
| 10722355001309 - Detector hCG | 2023-07-06 For the qualitative detection of hCG in urine |
| 10722355001316 - Detector hCG | 2023-07-06 For the qualitative detection of hCG in urine |
| 10722355001330 - Detector hCG Stick | 2023-07-06 For the qualitative detection of hCG in urine |
| 10722355001347 - Detector hCG Stick | 2023-07-06 For the qualitative detection of hCG in urine |
| 10722355001354 - Detector hCG Stick | 2023-07-06 For the qualitative detection of hCG in urine |
| 10722355001361 - Detector hCG Combi | 2023-07-06 For the qualitative detection of hCG in serum or urine |
| 10722355001378 - Detector hCG Combi | 2023-07-06 For the qualitative detection of hCG in serum or urine |