altadiagnostics.comMAGNESIUM REAGENT
ALTA DIAGNOSTICS, INC.
ALTA DIAGNOSTICS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2084170 | 2084170 | ALTA DIAGNOSTICS, INC. | 1 | N | 2026-01-01 | 3123 Research Way Ste 214 Carson City NV US 89706 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10858512007003 | NA - Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C. | 775-283-5780 | technical@altadiagnostics.com |
| 10858512007010 | NA - Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C. | 775-283-5780 | technical@altadiagnostics.com |
| 10858512007140 | NA - Liquid Human Spinal Fluid Control Level 1, 2 ml. 18 month open vial stability when stored at 2-8° C. | 775-283-5780 | technical@altadiagnostics.com |
| 10858512007157 | NA - Liquid Human Spinal Fluid Control Level 2, 2 ml. 18 month open vial stability when stored at 2-8° C. | 775-283-5780 | technical@altadiagnostics.com |
| 10858512007171 | NA - Liquid Human Spinal Fluid Control Level 1, 5 ml. 18 month open vial stability when stored at 2-8° C. | 775-283-5780 | technical@altadiagnostics.com |
| 10858512007188 | NA - Liquid Human Spinal Fluid Control Level 2, 5 ml. 18 month open vial stability when stored at 2-8° C. | 775-283-5780 | technical@altadiagnostics.com |
| 30858512007168 | NA - Liquid Human Spinal Fluid Control Level 1/Level 2, 2 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C. | 775-283-5780 | technical@altadiagnostics.com |
| 30858512007199 | NA - Liquid Human Spinal Fluid Control Level 1/Level 2, 5 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C. | 775-283-5780 | technical@altadiagnostics.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 42316 | 1737045822 | K890577 | KENLOR LIQUID URINE CONTROL | JJW | 1989-03-09 |
| 42316 | 1974571442 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JJW | 1 | 1989-03-09 |
PMN#
URIC ACID KIT
ALTA DIAGNOSTICS, INC.
FETAL CHECK
ALTA DIAGNOSTICS, INC.
AMYLASE REAGENT SET
ALTA DIAGNOSTICS, INC.
LIPASE REAGENT SET
ALTA DIAGNOSTICS, INC.
GUDID#
NA - Liquid Human Spinal Fluid Control Level 1, 2 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Human Spinal Fluid Control Level 2, 2 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Human Spinal Fluid Control Level 1, 5 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Human Spinal Fluid Control Level 2, 5 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Human Spinal Fluid Control Level 1/Level 2, 2 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Human Spinal Fluid Control Level 1/Level 2, 5 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control Dipstick - Positive, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control - Level 1, 10 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control - Level 2, 10 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control - Level 1, 25 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control - Level 2, 25 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control Dipstick - Negative, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control Dipstick - Positive, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control for Microscopic and High Specific Gravity - Positive, 250 ml. 18 month open vial stability when stored at 2-8° C. Contains Polystyrene and Latex.
2019-03-29
NA - Liquid Urine Control for Microscopic and High Specific Gravity - Negative, 250 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control - Level 1, 10 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control - Level 2, 10 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control - Level 1, 25 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control - Level 2, 25 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Human Spinal Fluid Control Level 1, 2 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Human Spinal Fluid Control Level 2, 2 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Human Spinal Fluid Control Level 1, 5 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Human Spinal Fluid Control Level 2, 5 ml. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control Dipstick - Negative/Positive, 20 ml. Contains 3 vials Negative and 3 vials Positive. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control Dipstick - Negative/Positive. Contains 2 vials Negative and 2 vials Positive. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control - Level 1/Level 2, 10 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C.
2019-03-29
NA - Liquid Urine Control - Level 1/Level 2, 25 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C.
2019-03-29