Treponema pallidum (Spirochete)

GUDID 00847627001375

BIOCARE MEDICAL LLC

Treponema pallidum antigen IVD, antibody
Primary Device ID00847627001375
NIH Device Record Key3631edd0-80ef-425e-8d74-7bd85c19b780
Commercial Distribution StatusIn Commercial Distribution
Brand NameTreponema pallidum (Spirochete)
Version Model NumberACA135C
Company DUNS806617825
Company NameBIOCARE MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627001375 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

On-Brand Devices [Treponema pallidum (Spirochete)]

00847627031730OPAA135T60
00847627027313ALA135G7
00847627001900APA135AA
00847627001351ACA135A
00847627001375ACA135C
00847627001368ACA135B
00847627035363AVA135G

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