First Signal
GUDID 00751774356113
PLPL First Signal SPS Early Result
SPD SWISS PRECISION DIAGNOSTICS GMBH
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical| Primary Device ID | 00751774356113 |
| NIH Device Record Key | f16dcba8-5629-4f15-9139-d29707c7748b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | First Signal |
| Version Model Number | Early Result Pregnancy Test |
| Company DUNS | 483609579 |
| Company Name | SPD SWISS PRECISION DIAGNOSTICS GMBH |
| 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 |
Customer Support Contacts
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00751774356113 [Primary] |
| GS1 | 10751774356110 [Package] Package: Shipping case [24 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042280
FDA Product Code
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-01-06 |
On-Brand Devices [First Signal ]
| 10751774356127 | PLPL First Signal DPS Early Result |
| 00751774356113 | PLPL First Signal SPS Early Result |
| 10751774013730 | First Signal 5D Pregnancy Cassette |
Trademark Results [First Signal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIRST SIGNAL 90367462 not registered Live/Pending |
Abbott Rapid Diagnostics International Unlimited Company 2020-12-08 |
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