FDA.report

Premom Pregnancy Test Cassette (25 test kit)

Primary DI
10855944007373
Brand
Premom Pregnancy Test Cassette (25 test kit)
Company
EASY HEALTHCARE CORPORATION
Model
PM1-C
Catalog number
PMC-125
Device description
Premom HCG Pregnancy Test Cassette (25 Pack of Individually-Sealed HCG Urine Tests with Pipette)
Published
2018-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LCXKit, Test, Pregnancy, Hcg, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10855944007373PackageGS172In Commercial Distribution
00855944007376PrimaryGS10
30855944007377Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085594400737310855944007373
00855944007376008559440073768559440073760855944007376
3085594400737730855944007377

GMDN Terms

TermDefinition
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080278407
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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