| Primary Device ID | 00853691007670 |
| NIH Device Record Key | 6b1b2741-dfcd-4f6f-a663-27db9a94e83f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | hCG Rapid Test Cassette 25 mIU/mL |
| Version Model Number | 1 |
| Company DUNS | 079697380 |
| Company Name | ACRO BIOTECH INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853691007670 [Primary] |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-07-03 |
| 00853691007113 - AMP Rapid Test Cassette | 2018-03-29 AMP Rapid Test Cassette |
| 00853691007120 - BZO Rapid Test Cassette | 2018-03-29 BZO Rapid Test Cassette |
| 00853691007137 - COC Rapid Test Cassette | 2018-03-29 COC Rapid Test Cassette |
| 00853691007151 - OPI Rapid Test Cassette | 2018-03-29 OPI Rapid Test Cassette |
| 00853691007168 - THC Rapid Test Cassette | 2018-03-29 THC Rapid Test Cassette |
| 00853691007205 - Pregnancy (hCG) Urine/Serum Combo Rapid Test Cassette | 2018-03-29 Pregnancy (hCG) Urine/Serum Combo Rapid Test Cassette |
| 00853691007229 - hCG Enhanced Sensitivity Rapid Test Cassette 10 mIU/mL | 2018-03-29 hCG Enhanced Sensitivity Rapid Test Cassette 10 mIU/mL |
| 00853691007595 - FOB Rapid Test Cassette | 2018-03-29 FOB Rapid Test Cassette |