| Primary Device ID | 10722355001293 |
| NIH Device Record Key | 7a37d3a2-7f0e-417e-8452-b5f0387be5cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Detector hCG |
| Version Model Number | IHD/P-100 |
| 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 | false |
| 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 | |
| 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 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10722355001293 [Primary] |
| GS1 | 80722355001292 [Unit of Use] |
| JHI | Visual, pregnancy hCG, prescription use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2023-07-06 |
| Device Publish Date | 2016-09-24 |
| 10722355002061 | For the qualitative detection of hCG in urine |
| 10722355001415 | For the detection of hCG in urine to aid in the determination of pregnancy |
| 10722355001316 | For the qualitative detection of hCG in urine |
| 10722355001309 | For the qualitative detection of hCG in urine |
| 10722355001293 | For the qualitative detection of hCG in urine |