FDA.report

Pointe Scientific Estradiol

Primary DI
00811727013286
Brand
Pointe Scientific Estradiol
Company
POINTE SCIENTIFIC, INC.
Model
S1111-96
Catalog number
S1111-96
Device description
Estradiol EIA Kit is for the quantitative determination of estradiol (E2) concentration in human serum. For in vitro diagnostic use only. 96 tests
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811727013286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727013286008117270132868117270132860811727013286

GMDN Terms

TermDefinition
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-445-9853techservice@medtest.com

Regulatory Flags

DUNS number
045623154
Device count
1
DM exempt
false
Premarket exempt
true
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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