SEEKER™ 1201

GUDID 00819704020081

SEEKER™ GAA Reagent (alpha-D-glucosidase)

BAEBIES, INC.

Newborn metabolic screen/congenital disorder IVD, reagent Newborn metabolic screen/congenital disorder IVD, reagent
Primary Device ID00819704020081
NIH Device Record Key60bc6dc7-fc47-4fe9-9bcc-14a48d73039e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSEEKER™
Version Model Number1201
Catalog Number1201
Company DUNS079264306
Company NameBAEBIES, INC.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(844) 244-4034
Emailtechsupport@baebies.com
Phone(844) 244-4034
Emailtechsupport@baebies.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -80 Degrees Celsius and -70 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100819704020081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PQUAlpha-D-Glucosidase (Gaa) Newborn Screening Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-04

On-Brand Devices [SEEKER™]

00819704020258SEEKER™ Personal Computer
00819704020241SEEKER™ Personal Computer
00819704020234SEEKER™ Personal Computer
00819704020227SEEKER™ Quality Control Dried Blood Spot Kit Contains 5 levels: QC Base Pool, QC Low, QC Inter
00819704020203SEEKER™ Instrument & Accessories The SEEKER™ Instrument is a quantitative in vitro diagnosti
00819704020197The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination
00819704020180SEEKER™ LSD Reagent Kit - IDUA GAA
00819704020173The SEEKER™ LSD Reagent Kit - IDUA|GAA|GBA|GLA is intended for quantitative measurement of the
00819704020166SEEKER™ Stop Buffer
00819704020159SEEKER™ Calibrant D
00819704020142SEEKER™ Calibrant C
00819704020135SEEKER™ Calibrant B
00819704020128SEEKER™ Calibrant A
00819704020111SEEKER™ GLA Reagent (alpha-D-galactosidase)
00819704020104SEEKER™ GBA Reagent (ß-Glucocerebrosidase)
00819704020098SEEKER™ IDUA Reagent (alpha-L-iduronidase)
00819704020081SEEKER™ GAA Reagent (alpha-D-glucosidase)
00819704020029SEEKER™ disposable Cartridge
00819704020012SEEKER™ Extraction Buffer
00819704020005SEEKER™ Filler Fluid

Trademark Results [SEEKER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SEEKER
SEEKER
98456110 not registered Live/Pending
CRÜZR SADDLES, LLC
2024-03-19
SEEKER
SEEKER
98445991 not registered Live/Pending
Pitsco Education, LLC
2024-03-12
SEEKER
SEEKER
98436353 not registered Live/Pending
Scotty Manufacturing Ltd.
2024-03-06
SEEKER
SEEKER
98409258 not registered Live/Pending
Seeker Unlimited, Inc.
2024-02-16
SEEKER
SEEKER
98362152 not registered Live/Pending
Strike IP
2024-01-17
SEEKER
SEEKER
98316685 not registered Live/Pending
X Development LLC
2023-12-15
SEEKER
SEEKER
98182578 not registered Live/Pending
TS-IP Holdings Ltd.
2023-09-15
SEEKER
SEEKER
98171181 not registered Live/Pending
Plastic Research and Development Corporation
2023-09-08
SEEKER
SEEKER
97400857 not registered Live/Pending
Clover8 Investments Pte. Ltd.
2022-05-09
SEEKER
SEEKER
97398959 not registered Live/Pending
TRANS-TEXAS TIRE, LLC
2022-05-06
SEEKER
SEEKER
97142253 not registered Live/Pending
SavantX, Inc.
2021-11-24
SEEKER
SEEKER
90881163 not registered Live/Pending
Terrafugia, Inc
2021-08-13

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