SAS Pregnancy Serum/Urine

GUDID 00780311000226

SAS™ Pregnancy Serum/Urine is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only.

SA SCIENTIFIC, LTD.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00780311000226
NIH Device Record Key0d4e9c15-50f7-41d0-b915-47f5a037e53f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAS Pregnancy Serum/Urine
Version Model Number087750-N
Company DUNS122092117
Company NameSA SCIENTIFIC, LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100780311000226 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-03
Device Publish Date2018-11-01

On-Brand Devices [SAS Pregnancy Serum/Urine]

00780311000226SAS™ Pregnancy Serum/Urine is a visual and rapid test for the qualitative determination of hum
00780311000011SAS™ Pregnancy Serum/Urine is a visual and rapid test for the qualitative determination of hum

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