OSOM hCG Combo Tests
OSOM hCG Urine/Serum Combo Test is a rapid immunoassay for thequalitative detection of human chorionic gonadotropin (hCG) in urine or serum. FDA Cleared and CLIA Waived for urine and Moderately Complex for Serum. (FDA 510K#: K043385)
OSOM hCG Combo Test:
-A rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy. This test is for use in physicians' office and clinical laboratories.
-CLIA Waived for urine
Product Features and Specifications:
Test Method: Solid phase, sandwich-format immunochromatographic assay.
Specimen Type: Serum or Urine
Specimen Delivery: No Drop Counting Pipette
Time to Result: Urine - 3 Minues, Serum - 5 Minutes
Sensitivity: Urine - 20mIU/mL, Serum - 10mIU/mL
Storage: Room Temperature
Shelf Life: 12-18 months from date of manufacture
Instructions: Pictorial procedure for convenient reference
Quantity: 25 Tests
Order No. GZM-124
CLIA: FDA Cleared
- 81025 - Urine pregnancy test (Waived)
- National Average Reimbursement 2019: $8.61
- 84703 - Chorionic gonadotropin assay (Moderate)
- National Average Reimbursement 2019: $8.36
*All CPT codes are supplied for information purposes only and represent no statement; promise or guarantee by CLIAwaived Inc. that these codes will be appropriate or that reimbursement will be made. It is the responsibility of the service provider to confirm the appropriate coding required by their local Medicare carriers, fiscal intermediaries and commercial payors.