METALS LEVEL 2

GUDID B80001696000021

Multiple heavy metal IVD, control

Primary Device ID	B80001696000021
NIH Device Record Key	7663d207-d775-49c8-bf87-2f879e724970
Commercial Distribution Status	In Commercial Distribution
Brand Name	METALS LEVEL 2
Version Model Number	MET T 2 WB UK
Company DUNS	092519016
Company Name	UTAK LABORATORIES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B80001696000020 [Primary]
HIBCC	B80001696000021 [Package] Contains: B80001696000020 Package: Box [4 Units] In Commercial Distribution
HIBCC	B80001696000022 [Package] Contains: B80001696000020 Package: Box [5 Units] In Commercial Distribution
HIBCC	B80001696000023 [Package] Contains: B80001696000020 Package: Box [10 Units] In Commercial Distribution
HIBCC	B80001696000026 [Package] Contains: B80001696000020 Package: Box [25 Units] In Commercial Distribution
HIBCC	B80001696000027 [Package] Contains: B80001696000020 Package: Box [50 Units] In Commercial Distribution
HIBCC	B80001696000028 [Package] Contains: B80001696000020 Package: Box [100 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false