Rite Aid Pharmacy

GUDID 00011822096973

FPPL Rite Aid SPS +/- (ER)

SPD SWISS PRECISION DIAGNOSTICS GMBH

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00011822096973
NIH Device Record Keyc7cc095a-2918-43fb-9177-643331fe2fd0
Commercial Distribution Discontinuation2021-02-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRite Aid Pharmacy
Version Model NumberFamily Planning Pregnancy Test One Step
Company DUNS483609579
Company NameSPD SWISS PRECISION DIAGNOSTICS GMBH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100011822096973 [Primary]
GS110011822096970 [Package]
Package: Shipping Case [24 Units]
Discontinued: 2021-02-11
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCXKit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-12
Device Publish Date2016-08-24

On-Brand Devices [Rite Aid Pharmacy]

10011822037249A convenience kit consisting of 1 Rite Aid Pharmacy Digital Pregnancy Test and 1 Rite Aid Pharma
10011822018163RITE AID DPS +/- 2ct Blue Cap
10011822515808Rite Aid DPS Early Bi-Ling
10011822510469FPPL Rite Aid TPS +/- (ER)
10011822473030Rite Aid TPS Early Result
10011822380062PLPL Rite Aid DPS Early Result
00011822337373WWOT Rite Aid OVS
10011822306642FPPL Rite Aid DPS +/- (ER)
00011822096973FPPL Rite Aid SPS +/- (ER)

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